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In addition, the Site Quality Head will have responsibility for the Quality Control laboratory performing chemistry and microbial testing. This leadership role will ensure robust processes and systems that meet compliance requirements and support the delivery of high-quality mRNA product for the local market or export. As a member of the Site Leadership Team, the Quality Head will drive a strong quality culture, deliver on production and testing commitments, and closely monitor performance. Here's What You'll Do: Establish and lead an organization responsible for supporting internal Drug Substance manufacturing operations as well as technology transfers and CQV at Moderna's Canadian site. Ensure the site operates in compliance with regulatory and GMP expectations to sustainably deliver high quality product. Ensure quality policies, procedures, and training are understood and implemented for the site as well as supportive programs and strategies including contamination control. Review and approve cGMP documentation (Change Management, Deviation Management, Batch Records, Protocols, Specifications, Technical Reports, CAPAs, etc) and ensure alignment with global processes and platforms. Ensure Quality Assurance presence on the manufacturing floor. Ensure the robust and timely execution of Batch Disposition. Establish and monitor key quality performance indicators to proactively identify and address quality system or product issues, and ensure stability, effectiveness, and improvement. Routinely analyze and present the health of the organization for transparency and to drive accountability. Establish and maintain a robust Quality Control laboratory able to meet business commitments. This should include testing execution as well as sample management, stability management, laboratory investigations, and performance monitoring. Interface directly with Health Canada or other regulatory authorities and ensure Moderna is appropriately represented in matters related to compliance and quality, especially in communications with the health authorities. Ensure inspection readiness and provide guidance and support relative to Good Manufacturing Practices (GMPs). Design, build, and continuously develop a high-functioning Quality organization connected with the company's strategic goals and quality objectives. Role model Quality Culture and the Moderna Mindsets Contribute as an active and engaged member of the site leadership team as well as global Quality leadership teams Coach and mentor direct reports and others across the QA organization and site Champion continuous improvement in all aspects of total quality management through a well-trained workforce, streamlined business processes, and appropriate structured quality operations. Develop resource strategies, allocate budget, and assess / build capabilities necessary to support effective and efficient operations. Additional duties as may be assigned. Here's What You'll Bring to the Table: Bachelor's or Master's degree, preferably in Sciences (Biology, Microbiology, Chemistry, Pharmacy) or Engineering, or equivalent combination of education and experience. 10+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices Demonstrated ability to analyze complex issues and situations Excellent leadership skills with the ability to operate independently, collaborate cross-functionally, and foster a positive culture Previous experience with Quality Control, preferred Le r\u00f4le : Sous la responsabilit\u00e9 du Responsable Mondial de la Qualit\u00e9 des Substances M\u00e9dicamenteuses Commerciales, avec un lien hi\u00e9rarchique indirect avec le Responsable Mondial du Contr\u00f4le de la Qualit\u00e9, le Responsable de la Qualit\u00e9 du Site sera charg\u00e9 de fournir un leadership et une supervision en assurance qualit\u00e9 pour les op\u00e9rations de substances m\u00e9dicamenteuses de Moderna sur le site de fabrication au Canada. De plus, le Responsable de la Qualit\u00e9 du Site sera responsable du laboratoire de contr\u00f4le qualit\u00e9 effectuant des tests chimiques et microbiologiques. Ce r\u00f4le de leadership garantira des processus et des syst\u00e8mes solides r\u00e9pondant aux exigences de conformit\u00e9 et soutenant la confection de produits ARNm de haute qualit\u00e9 pour le march\u00e9 local ou \u00e0 l'exportation. En tant que membre de l'\u00e9quipe de direction du site, le Responsable de la Qualit\u00e9 favorisera une culture de qualit\u00e9 forte, respectera les engagements de production et de test, et surveillera \u00e9troitement les performances. Voici ce que vous ferez : \u00c9tablir et diriger une organisation charg\u00e9e de soutenir les op\u00e9rations internes de fabrication de substances m\u00e9dicamenteuses, ainsi que les transferts de technologie et la validation des \u00e9quipements et des proc\u00e9d\u00e9s (CQV) sur le site de Moderna au Canada. Veiller \u00e0 ce que le site fonctionne en conformit\u00e9 avec les attentes r\u00e9glementaires et les BPF afin de fournir durablement un produit de haute qualit\u00e9. Veiller \u00e0 ce que les politiques, proc\u00e9dures et formations en mati\u00e8re de qualit\u00e9 soient comprises et mises en \u0153uvre sur le site, ainsi que les programmes et strat\u00e9gies de soutien, y compris le contr\u00f4le de la contamination. Examiner et approuver la documentation des BPF (gestion des changements, gestion des \u00e9carts, enregistrements de lots, protocoles, sp\u00e9cifications, rapports techniques, CAPA, etc.) et veiller \u00e0 leur alignement avec les processus et plates-formes mondiaux. Assurer la pr\u00e9sence de l'Assurance Qualit\u00e9 dans l'atelier de fabrication. Garantir l'ex\u00e9cution robuste et en temps voulu de la lib\u00e9ration des lots. \u00c9tablir et surveiller les indicateurs cl\u00e9s de performance qualit\u00e9 pour identifier et r\u00e9soudre de mani\u00e8re proactive les probl\u00e8mes du syst\u00e8me qualit\u00e9 ou du produit, et assurer la stabilit\u00e9, l'efficacit\u00e9 et l'am\u00e9lioration. Analyser r\u00e9guli\u00e8rement et pr\u00e9senter l'\u00e9tat de sant\u00e9 de l'organisation pour favoriser la transparence et la responsabilit\u00e9. \u00c9tablir et maintenir un laboratoire de contr\u00f4le qualit\u00e9 solide capable de respecter les engagements commerciaux. Cela devrait inclure l'ex\u00e9cution des tests ainsi que la gestion des \u00e9chantillons, la gestion de la stabilit\u00e9, les investigations de laboratoire et le suivi des performances. Interagir directement avec Sant\u00e9 Canada ou d'autres autorit\u00e9s r\u00e9glementaires et veiller \u00e0 ce que Moderna soit repr\u00e9sent\u00e9e de mani\u00e8re appropri\u00e9e dans les questions li\u00e9es \u00e0 la conformit\u00e9 et \u00e0 la qualit\u00e9, notamment dans les communications avec les autorit\u00e9s sanitaires. Assurer la pr\u00e9paration aux inspections et fournir des orientations et un soutien en mati\u00e8re de Bonnes Pratiques de Fabrication (BPF). Concevoir, construire et d\u00e9velopper en continu une organisation de qualit\u00e9 performante en lien avec les objectifs strat\u00e9giques et les objectifs qualit\u00e9 de l'entreprise. Mod\u00e9liser la culture de la qualit\u00e9 et les mentalit\u00e9s de Moderna. Contribuer en tant que membre actif et engag\u00e9 de l'\u00e9quipe de direction du site ainsi que des \u00e9quipes de direction qualit\u00e9 mondiales. Encadrer et guider les collaborateurs directs et les autres membres de l'organisation de l'Assurance Qualit\u00e9 et du site. Promouvoir l'am\u00e9lioration continue dans tous les aspects de la gestion de la qualit\u00e9 totale gr\u00e2ce \u00e0 une main-d'\u0153uvre bien form\u00e9e, des processus m\u00e9tier rationalis\u00e9s et des op\u00e9rations qualit\u00e9 structur\u00e9es appropri\u00e9es. D\u00e9velopper des strat\u00e9gies de ressources, allouer des budgets et \u00e9valuer/construire les comp\u00e9tences n\u00e9cessaires pour soutenir des op\u00e9rations efficaces et efficientes. Toutes autres t\u00e2ches qui pourraient \u00eatre assign\u00e9es. Voici ce que vous apporterez : Un dipl\u00f4me de bachelier ou de ma\u00eetrise, de pr\u00e9f\u00e9rence en sciences (biologie, microbiologie, chimie, pharmacie) ou en ing\u00e9nierie, ou une combinaison \u00e9quivalente d'\u00e9tudes et d'exp\u00e9rience. Plus de 10 ans d'exp\u00e9rience dans l'industrie pharmaceutique ou dans un domaine connexe, avec une emphase sur les bonnes pratiques de fabrication actuelles. Capacit\u00e9 d\u00e9montr\u00e9e \u00e0 analyser des probl\u00e8mes et des situations complexes. Excellentes comp\u00e9tences en leadership, avec la capacit\u00e9 de travailler de mani\u00e8re autonome, de collaborer de mani\u00e8re transversale et de favoriser une culture positive. Exp\u00e9rience ant\u00e9rieure en contr\u00f4le qualit\u00e9, de pr\u00e9f\u00e9rence. Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work. We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with: Quality healthcare and insurance benefits Lifestyle Spending Accounts to create your own pathway to well-being Free premium access to fitness, nutrition, and mindfulness classes Family planning and adoption benefits Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown Educational resources Savings and investments Location-specific perks and extras! The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Moderna is a smoke-free, alcohol-free and drug-free work environment. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is proud to be an equal opportunity workplace and is an affirmative action employer. Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. 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Provides support to audit teams for Health authority, Internal/External and vendor audits. Ensures teams perform tasks as needed to maintain GMP compliance.\u200b Evaluate, align, and oversee QC data analytics, monitoring, and trending (e.g., method and product performance trending). Works with Digital/IT to continually strengthen data integrity across the QC testing laboratories. Minimum education required: Bachelor's Degree in a relevant scientific discipline. Minimum experience required: 10 + years in applied industry experience; 4-6 years of management/supervisory experience. Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs. Previous supervisory experience is preferred, including testing scheduling and lab project management. Minimum knowledge required: general laboratory operations, method acquisition, qualification. Technical writing. Proficiency with Microsoft Office Programs. Familiarity with electronic databases (e.g., LIMS, SAP, LMS). Familiarity with QC operations including bioassay, chemistry, and microbiology. HPLC Instrumentation/ Software experience is preferred. Strong written and oral communication skills as well as organizational skills. Knowledge of industry standards and guidelines, experience supporting compliance audits. Demonstrated ability to work effectively under established guidelines and instructions. Ability to collaborate effectively in a dynamic, cross-functional matrix environment. Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations. Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309255364637", "isPrivate": false}, {"id": 309256683770, "name": "Specialist, Quality Assurance - On the Floor", "location": "Laval - Canada", "locations": ["Laval - Canada"], "hot": 0, "department": "Quality", "business_unit": "Unknown", "t_update": 1702136054, "t_create": 1699574400, "ats_job_id": "R14672", "display_job_id": "R14672", "type": "ATS", "id_locale": "R14672-en", "job_description": "The Role: Moderna is seeking a Quality Assurance Specialist responsible for real time on the floor quality oversight of internal manufacturing at Moderna Inc. The individual in this role will be part of a cohesive team responsible for supporting cGMP mRNA drug substance produced internally at Moderna and will work cross-functionally with Operations, Manufacturing Science and Technology, and other functions. They will provide real time quality oversight and expertise to enable technical success with stringent adherence to the Quality System. Strong decision-making skills and independent thinking will be paramount for candidate success. They will be expected to make decisions and/or escalate issues to management that occur during operations. Here's What You'll Do: Provide on-the-floor Quality support to Manufacturing including real-time observation of activities. Monitor process operations to ensure compliance with specifications. Make quality decisions and/or escalates issues to management that may impact operations. Identify risks and communicate gaps for quality and GMP process/systems Perform routine walkthroughs of the manufacturing suites to ensure appropriate suite maintenance, implementation of GMP best practices, and troubleshooting when problems arise. Enforce adherence to cGMPs, SOPs, and manufacturing documentation. Partner with manufacturing and support teams to initiate and triage new deviation events, reviews minor manufacturing deviations. Author and review documentation, including SOPs and WIs, to ensure compliance and adherence to regulations/cGMP operations. Review executed electronic and paper batch record documentation. Practice safe work habits and adhere to Moderna's safety procedures and guidelines. Utilize knowledge to improve operational efficiency. Operate on a shift structure Here's What You'll Bring to the Table: Bachelor's Degree in a science field (e.g., Biology, Microbiology, Chemistry, Pharmacy, Engineering) or equivalent combination of education and experience 3 - 5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices Le R\u00f4le : Moderna recherche un Sp\u00e9cialiste en Assurance Qualit\u00e9 pour assurer la surveillance en temps r\u00e9el de la qualit\u00e9 de la fabrication interne chez Moderna Inc. Le titulaire du poste int\u00e9grera une \u00e9quipe d\u00e9di\u00e9e au soutien de la substance m\u00e9dicamenteuse d'ARNm conforme aux cGMP produite en interne chez Moderna, et collaborera avec les Op\u00e9rations, la Science et la Technologie de Fabrication, ainsi que d'autres fonctions. Il apportera une expertise et une surveillance de la qualit\u00e9 en temps r\u00e9el pour garantir un succ\u00e8s technique tout en respectant rigoureusement le Syst\u00e8me de Qualit\u00e9. Une capacit\u00e9 \u00e0 prendre des d\u00e9cisions de mani\u00e8re autonome sera essentielle \u00e0 la r\u00e9ussite du candidat. Il sera attendu du titulaire du poste qu'il prenne des d\u00e9cisions et/ou escalade les probl\u00e8mes \u00e0 la direction survenant lors des op\u00e9rations. Voici Ce Que Vous Ferez : Assurer un soutien Qualit\u00e9 sur le terrain \u00e0 la Fabrication, y compris l'observation en temps r\u00e9el des activit\u00e9s. Veiller \u00e0 la conformit\u00e9 des op\u00e9rations de processus aux sp\u00e9cifications. Prendre des d\u00e9cisions de qualit\u00e9 et/ou escalader les probl\u00e8mes \u00e0 la direction susceptibles d'affecter les op\u00e9rations. Identifier les risques et communiquer les lacunes en mati\u00e8re de qualit\u00e9 et des processus/syst\u00e8mes GMP. R\u00e9aliser des visites r\u00e9guli\u00e8res des suites de fabrication pour garantir un entretien appropri\u00e9, la mise en \u0153uvre des meilleures pratiques GMP, et intervenir en cas de probl\u00e8mes. Veiller au respect des cGMP, des SOP, et de la documentation de fabrication. Collaborer avec les \u00e9quipes de fabrication et de soutien pour initier et trier les nouveaux \u00e9v\u00e9nements de d\u00e9viation, et examiner les d\u00e9viations mineures de fabrication. R\u00e9diger et r\u00e9viser la documentation, y compris les SOP et les WI, pour assurer la conformit\u00e9 et le respect des op\u00e9rations/r\u00e9glementations cGMP. Examiner la documentation ex\u00e9cut\u00e9e des dossiers de lot \u00e9lectroniques et papier. Respecter les habitudes de travail s\u00fbres et adh\u00e9rer aux proc\u00e9dures et directives de s\u00e9curit\u00e9 de Moderna. Utiliser les connaissances pour am\u00e9liorer l'efficacit\u00e9 op\u00e9rationnelle. Travailler selon une structure de quarts de travail. Voici Ce Que Vous Apporterez \u00e0 la Table : Dipl\u00f4me de baccalaur\u00e9at dans un domaine scientifique (par exemple, Biologie, Microbiologie, Chimie, Pharmacie, Ing\u00e9nierie) ou combinaison \u00e9quivalente d'\u00e9ducation et d'exp\u00e9rience 3 \u00e0 5 ans d'exp\u00e9rience de travail en pharmacie ou dans un domaine connexe, avec un accent sur les Bonnes Pratiques de Fabrication actuelles Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work. We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with: Quality healthcare and insurance benefits Lifestyle Spending Accounts to create your own pathway to well-being Free premium access to fitness, nutrition, and mindfulness classes Family planning and adoption benefits Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown Educational resources Savings and investments Location-specific perks and extras! The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Moderna is a smoke-free, alcohol-free and drug-free work environment. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is proud to be an equal opportunity workplace and is an affirmative action employer. Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer) LI-DS2 -", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256683770", "isPrivate": false}, {"id": 309256698186, "name": "Analyst, Quality Control - Microbiology & Bioassay", "location": "Laval - Canada", "locations": ["Laval - Canada"], "hot": 0, "department": "Quality", "business_unit": "Unknown", "t_update": 1702136828, "t_create": 1699833600, "ats_job_id": "R14679", "display_job_id": "R14679", "type": "ATS", "id_locale": "R14679-en", "job_description": "Execute GMP QC Molecular Biology methods, focusing on molecular and protein analytics, but also supporting ELISA, Cell-Based Potency testing, and other methodologies as needed. Execute GMP QC Microbiology methods, focusing on Sterility testing, Bioburden Analysis, Endotoxin, Micro sequencing in addition to other general methods such as TOC and Conductivity testing and other methodologies as needed. Support testing for drug substances and drug products, including generation of testing data to support other studies as needed. Conduct analysis related to Bioassay and Microbiology laboratory such as: TOC, Conductivity, Bioburden, Sterility, and Endotoxin, Identification by Sanger Sequencing, qPCR methods execution, ELISA, Cell-Based Potency testing and others. Perform routine environmental monitoring and critical utility sampling activities, if required Collaborate with AS&T groups on new methods transfers. Participated in method transfer projects for internal and external testing labs. Assist in development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements. Provide support to audit teams for internal and vendor audits. Prepare and ship/receive contract laboratory testing samples including those intended for microbiological identification. Perform general laboratory support activities including reagent preparation, equipment maintenance and housekeeping. May participate in equipment and method qualifications, validations, and method transfers. Perform data entry utilizing good documentation practices. May assist with troubleshooting assay methods and equipment. Supports more junior staff with data review, training, and troubleshooting. Participate in authoring quality systems records such as investigation, deviations, change controls, CAPAs; Write/revise SOPs, protocols, and reports. BSc/BA in a relevant scientific discipline with 5 years Quality Control experience in a cGMP organization with a focus in Molecular Biology, DNA Sequencing and Microbiology. Hands on experience with molecular biology techniques including, but not limited to, gel electrophoresis, qPCR, and Sanger Sequencing. Hands-on experience of various Microbiology testing techniques and analyses (e.g. Vitek, Isolator Technology, Bioburden, BET, Sterility, others) Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred. Working experience in a GMP environment. Ability to collaborate effectively in a dynamic, cross-functional matrix environment. Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment. Proven ability to conduct investigations.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256698186", "isPrivate": false}, {"id": 309256698216, "name": "Analyst, Quality Control - Chemistry & Stability", "location": "Laval - Canada", "locations": ["Laval - Canada"], "hot": 0, "department": "Quality", "business_unit": "Unknown", "t_update": 1702136579, "t_create": 1699833600, "ats_job_id": "R14681", "display_job_id": "R14681", "type": "ATS", "id_locale": "R14681-en", "job_description": "Performs routine analytical chemistry & stability testing including, but not limited to HPLC, UPLC, GC, UV, Particle Analysis by Dynamic Light Scattering, KF, etc. Perform HPLC (AEX) and NaOH plate reader-based assays in support of manufacturing process stat testing as needed. Complete and maintain cGMP documentation for work performed. Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping etc. Establish and maintain a safe laboratory working environment. LIMS (LabVantage) sample result entry, execution of Electronic Assay Forms in LIMS. Assists with and executes on ordering of laboratory consumables and supplies. Managing/stocking of QC lab supplies. Performs stability responsibilities in compliance and in support of any stability program and associated SOP's. Creates, reviews and revises stability protocols and reports. Assists with and performs stability set down and stability pull activities to include, but not limited to labeling, verifying sample quantities, and updating in LIMS and/or appropriate logs/inventory sheets; Supports routine stability sample inventory management, assessment, and sample disposal activities. Assists with creating stability schedules for GMP stability drug substances and drug products and ensures stability sample pulls occur and are distributed to the test labs as scheduled and within appropriate timelines. Performs the required functions for stability studies in LIMS, including data entry review and approval. Assists with and supports reporting of stability testing results both externally and cross-functionally. Performs trending of stability data and statistical analyses and maintains/ keeps current stability tables and charts for all stability studies. Supports and executes stability sample shipments to external labs; Requests and retrieves stability testing data/reports from external vendors and shared folders and updates in-house stability binders and databases accordingly. Supports review and authoring of applicable stability sections for regulatory submissions. May assist with troubleshooting assay methods and equipment. Supports more junior staff with data review, training, and troubleshooting. Participate in authoring quality systems records such as investigation, deviations, change controls, CAPAs; Write/revise SOPs, protocols, and reports. BA/BSc in Chemistry (preferred) or other relevant scientific discipline. Working experience: at least 5-7 years in quality control laboratory of a pharmaceutical company.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256698216", "isPrivate": false}, {"id": 309255538906, "name": "Validation Manager", "location": "Laval - Canada", "locations": ["Laval - Canada"], "hot": 0, "department": "Engineering", "business_unit": "Jerh Collins", "t_update": 1702135764, "t_create": 1694131200, "ats_job_id": "R14195", "display_job_id": "R14195", "type": "ATS", "id_locale": "R14195-en", "job_description": "Provide guidance / supervision to staff and external validation service providers. Track and report status on metrics relevant to the re-qualification program activities / responsibilities and ensure commitment to key stakeholders are met. Ensure the validated status of site facilities, utilities, equipment, and processes is established and maintained in accordance with internal procedures, regulatory requirements, and industry guidance / standards. Leads and reviews deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, methods, and laboratory instruments. Leads and/or participates in multi-functional department teams for validated process, equipment, utilities, method, and computer systems, to meet established timeframe for project implementations that support business needs and meet global regulatory requirements. Support internal and external inspections as a Subject Matter Expert for Commissioning, Qualification and Validation. Participate in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs. Oversight of contractors/consultants in the day-to-day execution of CQV scope, including ensuring adequate qualifications and training, oversight/review of their effort, and management of their priorities and work product. Define and execute the validation strategy associated with site projects covering a range of facilities, utilities, equipment, and processes in accordance with project timelines and customer expectations. Drive results by owning and completing validation initiatives / projects against identified timelines. Own quality records such as Change Controls, Deviations, Corrective / Preventative Actions (CAPAs), and continuous improvement initiatives related to validation activities. Present validation documentation during regulatory / internal / customer audits. Participate in the response to regulatory audit observations, as required. Maintain an awareness of regulatory and industry best practice trends, hot topics and changes in relation to validation. B.S. in Chemical or Mechanical Engineering. Minimum of 7+ years in commissioning / qualification / validation experience in a Sterile cGMP manufacturing environment. Proven experience leading teams; prior supervisory experience preferred. Strong understanding of validation principles including but not limited to facilities, utilities, systems and equipment (FUSE). Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission / inspection. Must be able use his / her technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions. Must be able to be able to find true root cause and path forward for complex problems. Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions. Technical writing skills required. Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his / her manager.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309255538906", "isPrivate": false}, {"id": 309256683894, "name": "QA Operations Head", "location": "Laval - Canada", "locations": ["Laval - Canada"], "hot": 0, "department": "Quality", "business_unit": "Jerh Collins", "t_update": 1702136100, "t_create": 1699574400, "ats_job_id": "R14670", "display_job_id": "R14670", "type": "ATS", "id_locale": "R14670-en", "job_description": "Manage a team of QA professional responsible for: On-the-Floor manufacturing oversight, Deviation Management, Change Management, Batch Record Review and Product Disposition. Demonstrate dynamic range with the capability to also directly support these expectations. Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Monitor key quality system metrics and process indicators to ensure adherence to compliance and performance expectations. Engage in plant tiered governance that supports performance expectations that includes quality, delivery, and safety. Collaborate closely with cross-functional partners and as an active member of leadership. Support the training and development of the QA team including coordination of training, capability assessment and enhancement, and professional development. Author, review and/or approve documentation, including SOPs, to ensure compliance and adherence to regulations/cGMP operations. Be a champion for continuous improvement in all aspects of total quality management through a well-trained workforce, streamlined business processes, and appropriate structured quality operations. Utilize knowledge to improve operational efficiency. Ensure inspection readiness and provide guidance and support relative to Good Manufacturing Practices (GMPs). Bachelor's Degree in a science field (e.g., Biology, Microbiology, Chemistry, Pharmacy, etc.) or equivalent combination of education and experience 8 - 10+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices Demonstrated ability making risk based decisions Dipl\u00f4me de baccalaur\u00e9at dans un domaine scientifique (par exemple, Biologie, Microbiologie, Chimie, Pharmacie, etc.) ou combinaison \u00e9quivalente d'\u00e9ducation et d'exp\u00e9rience 8 \u00e0 10 ans ou plus d'exp\u00e9rience de travail en pharmacie ou dans un domaine connexe, avec un accent sur les Bonnes Pratiques de Fabrication actuelles Capacit\u00e9 d\u00e9montr\u00e9e \u00e0 prendre des d\u00e9cisions bas\u00e9es sur le risque", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256683894", "isPrivate": false}, {"id": 309256619972, "name": "Team Lead - mRNA Vaccines Production (Supervisor) \u2013 Night Shift", "location": "Laval - Canada", "locations": ["Laval - Canada"], "hot": 0, "department": "Manufacturing and Operations", "business_unit": "Jerh Collins", "t_update": 1702136941, "t_create": 1699315200, "ats_job_id": "R14652", "display_job_id": "R14652", "type": "ATS", "id_locale": "R14652-en", "job_description": "Operations and Production Management Manage all production operations and his team. Monitor team performance in accordance with key performance indicators in place and take necessary actions as needed. Collaborate with Supply Chain for planning: schedules, inventories, capacity. Manage/participate in several projects (processes, continuous improvement, equipment) in a fast-pace changing environment. Ensure the application of cGMP, SOPs and health and safety rules in production areas. Participate in the development of batch records, SOPs and training materials, for operational, cGMP and health and safety processes. Work closely with QA peers to complete the necessary documentation for the release of commercial batches on time. Investigate and participate in the writing of quality deviations as well as health and safety incidents in collaboration with the support departments. Oversee the training, development, retention and performance of personnel for the execution of manufacturing operations. Manage team performance (recognition and rewards, succession plan as well as non-performance) through periodic interviews. Develop operational plans to ensure the success of the direct team and good communication with other teams on the commercial platform. Effectively communicate information relating to the production to management. 5 to 10 years of experience in a GMP manufacturing environment. 3 years of experience in personnel management University degree in science/engineering. Ability to collaborate fluidly with peers, supervisors and support departments. Excellent writing, oral communication and organizational skills are required. Experience in chromatography and tangential flow filtration would be an asset. Experience preparing for audits and inspections, understanding health and regulatory authority guidelines. Superviser la formation, le d\u00e9veloppement, la r\u00e9tention et la performance du personnel pour l'ex\u00e9cution des op\u00e9rations de fabrication. G\u00e9rer les performances de l'\u00e9quipe (reconnaissance et r\u00e9compenses, planification de la succession ainsi que la non-performance) par des entretiens p\u00e9riodiques. \u00c9laborer les plans op\u00e9rationnels pour assurer la r\u00e9ussite de l'\u00e9quipe directe et la communication avec les autres \u00e9quipes de la plateforme commerciale. Transmettre efficacement \u00e0 la direction les informations relatives \u00e0 l'ensemble de la production.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256619972", "isPrivate": false}, {"id": 309256683994, "name": "Compliance Head", "location": "Laval - Canada", "locations": ["Laval - Canada"], "hot": 0, "department": "Quality", "business_unit": "Jerh Collins", "t_update": 1702136814, "t_create": 1699574400, "ats_job_id": "R14671", "display_job_id": "R14671", "type": "ATS", "id_locale": "R14671-en", "job_description": "Ensure continuous improvement while keeping current with emerging and changing regulations, guidance documents and industry best practices and expectations. Provide cross functional quality leadership and act as a GXP compliance subject matter expert. Serve as the site's Quality process owner for, at a minimum, Deviation Management, Change Management, Notifications to Management / Escalations, Material Review Boards, Complaints, Quality Management Reviews, and Health Authority reporting. Oversee the performance and effectiveness of the QMS programs listed as well as Quality Risk Management, Training, Documentation and Records Management, and Data Integrity. Maintain the site in a constant state of inspection readiness including the hosting of inspections. Be capable of running an effective and efficient backroom, and engage directly with Health Authority inspectors in the front room. Evaluate business goals, identify improvement opportunities, utilize critical thinking, and apply problem-solving techniques to improve and sustain product quality and process effectiveness in the overall QMS lifecycle. Serve as the site compliance representative on Global Compliance Councils, providing meaningful feedback on the QMS and how it impacts the site. Ensure awareness by the site of changes / initiatives and lead compliant implementation. Work collaboratively with the Compliance organizations across Global and the sites, along with the digital team, in order to drive effective and efficient processes supported with digital e-systems. Build sustainable processes that enable compliant execution. Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience of 10+ years. Demonstrated experience with Pharmaceutical Quality Systems. Inspection experience preferred Dipl\u00f4me de baccalaur\u00e9at, de pr\u00e9f\u00e9rence en Sciences ou en Ing\u00e9nierie avec une exp\u00e9rience industrielle de Qualit\u00e9 appliqu\u00e9e de plus de 10 ans. Exp\u00e9rience d\u00e9montr\u00e9e avec les Syst\u00e8mes de Qualit\u00e9 Pharmaceutique. Exp\u00e9rience en inspection pr\u00e9f\u00e9r\u00e9e", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256683994", "isPrivate": false}, {"id": 309256683996, "name": "QA Technical Operations Lead", "location": "Laval - Canada", "locations": ["Laval - Canada"], "hot": 0, "department": "Quality", "business_unit": "Jerh Collins", "t_update": 1702136946, "t_create": 1699574400, "ats_job_id": "R14669", "display_job_id": "R14669", "type": "ATS", "id_locale": "R14669-en", "job_description": "The Role: Reporting to the Site Quality Head, the QA Technical Operations Lead will be part of a cohesive team responsible for supporting cGMP mRNA drug substances produced internally at Moderna. This individual will demonstrate dynamic range with the capability to provide quality oversight of the manufacturing operations, technology transfer projects, or other GMP facility aspects. The successful candidate will have experience in quality oversight or manufacturing experience in commercial products. Here's What You'll Do: Provide Quality oversight for commissioning, qualification, and validation initiatives including complex GMP facility or critical utility projects Provide Quality oversight of product Technology Transfers Provide Quality oversight of significant deviations, including root cause analysis records, and change controls Provide Quality oversight of the site Contamination Control Strategy Review protocols, risk assessments, facility changes, and / or control strategies Writes, reviews, and approves GMP documentation. (SOPs, Forms, Technical Reports, Specifications, etc.) Participate in Internal and External Audits, including Health Authority inspections Collaborate cross-functionally to enable Quality Culture and a continuous improvement mindset Here's What You'll Bring to the Table: Bachelor's Degree in a science field (e.g., Engineering, Chemistry) or equivalent combination of education and experience 8 - 10+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices Demonstrated ability making risk based decisions Le R\u00f4le : Relevant du Chef de la Qualit\u00e9 du site, le Responsable des Op\u00e9rations Techniques QA int\u00e9grera une \u00e9quipe d\u00e9di\u00e9e au soutien des substances m\u00e9dicamenteuses d'ARNm conformes aux cGMP produites en interne chez Moderna. Ce professionnel devra faire preuve de dynamisme, capable d'assurer une surveillance de la qualit\u00e9 des op\u00e9rations de fabrication, des projets de transfert de technologie, ou d'autres aspects des installations GMP. Le candidat retenu devra avoir une exp\u00e9rience en surveillance de la qualit\u00e9 ou en fabrication de produits commerciaux. Voici Ce Que Vous Ferez : Superviser les initiatives de mise en service, de qualification, et de validation du point de vue Qualit\u00e9, y compris les projets complexes d'installations GMP ou d'utilit\u00e9s critiques. Assurer la supervision de la Qualit\u00e9 des Transferts de Technologie de produits. Surveiller la Qualit\u00e9 des d\u00e9viations significatives, y compris les dossiers d'analyse des causes racines, et les contr\u00f4les de changement. Superviser la Qualit\u00e9 de la Strat\u00e9gie de Contr\u00f4le de la Contamination du site. Examiner les protocoles, les \u00e9valuations des risques, les changements d'installations, et/ou les strat\u00e9gies de contr\u00f4le. R\u00e9diger, r\u00e9viser, et approuver la documentation GMP. (SOP, Formulaires, Rapports Techniques, Sp\u00e9cifications, etc.) Participer aux Audits Internes et Externes, y compris les inspections des Autorit\u00e9s Sanitaires. Collaborer de mani\u00e8re transversale pour promouvoir la Culture de la Qualit\u00e9 et une mentalit\u00e9 d'am\u00e9lioration continue. Voici Ce Que Vous Apporterez \u00e0 la Table : Dipl\u00f4me de baccalaur\u00e9at dans un domaine scientifique (par exemple, Ing\u00e9nierie, Chimie) ou combinaison \u00e9quivalente d'\u00e9ducation et d'exp\u00e9rience 8 \u00e0 10 ans ou plus d'exp\u00e9rience de travail en pharmacie ou dans un domaine connexe, avec un accent sur les Bonnes Pratiques de Fabrication actuelles Capacit\u00e9 d\u00e9montr\u00e9e \u00e0 prendre des d\u00e9cisions bas\u00e9es sur le risque Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work. We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with: Quality healthcare and insurance benefits Lifestyle Spending Accounts to create your own pathway to well-being Free premium access to fitness, nutrition, and mindfulness classes Family planning and adoption benefits Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown Educational resources Savings and investments Location-specific perks and extras! The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Moderna is a smoke-free, alcohol-free and drug-free work environment. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is proud to be an equal opportunity workplace and is an affirmative action employer. Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. 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