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Manage audit related observations and CAPAs. Work closely with Digital Technology department, system owners and business owners to implement new systems/instruments/equipment effectively and efficiently, system upgrades, or system modifications. Participate in the change control program for modifications to qualified systems and/or implementation of new systems. Review and approve computerized system, GcLP laboratory instruments, and GcLP equipment related documents and procedures. Support regulatory agency inspections as needed. Participate and actively engage in strategic initiatives which require CSV support. Provide support and input into the full CSV and SDLC program. Contribute to the continuing development of a quality culture at Moderna. Perform other tasks as assigned by line manager. BS/BA with 8 to 10 years of experience or MS with 5 to 8 years of experience in pharmaceutical / biotech industry with experience in the R&D Computer Systems Validation GCP/GLP/GVP environment. Demonstrated ability to work in a risk-based CSV environment following the associated regulatory expectations. Knowledge of Software Development Life Cycle (SDLC) principals including planning, analysis, design, development, testing, implementation, and maintenance is required. Experience and practical understanding of the development and validation of custom GAMP category 5 software, modules, interfaces, and reports is desired. Experience and proficiency with CSV audit for Research computerized systems is desired. Practical understanding of GAMP and ERES standards and guidance. Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for validation expectations (understanding of regulatory guidelines for other countries a plus), CFR 21 Part 11. Expertise with business office applications, word processing and spreadsheets. Demonstrated knowledge and/or prior experience in Quality Assurance and oversight of GVP systems such as Argus and Signal Detection. Outstanding communication skills (verbal and written) Ability to manage multiple projects in a fast-paced environment. Ability to collaborate effectively in a dynamic, cross-functional matrix environment. Ability to make decisions that are guided by policies, procedures, and business plan; receives guidance and oversight from manager. Relies on experience and judgment to plan and accomplish goals. Excellent organizational skills and keen attention to detail.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309253932262", "isPrivate": false}, {"id": 309255832229, "name": "2024 Co-Op, Digital for Core", "location": "Norwood, Massachusetts", "locations": ["Norwood, Massachusetts"], "hot": 0, "department": "Campus Programs", "business_unit": "Unknown", "t_update": 1701572391, "t_create": 1695600000, "ats_job_id": "R14310", "display_job_id": "R14310", "type": "ATS", "id_locale": "R14310-en", "job_description": "Engage with Clinical and Supply chain stakeholders to support and provide updates on digital initiatives for clinical studies. Author, Review and update technical specification documents required to deploy digital solutions. Conduct training for end users on new Digital functionality. Participate in customer meetings, which will include gathering requirements, providing progress updates, and conducting demos. Organize and lead planning and review sessions with the team based on customer requirements throughout the project lifecycle. Engage in regular pair-programming and group work sessions, \"hacking party\" style, using JavaScript/TypeScript (Angular, Node.js). Conduct code review sessions for moderate to major tasks and project development milestones. Provide regular progress reports in daily standup meetings. Present a final report detailing the work achieved and the business value of the final product. Additional duties as may be assigned from time to time. Rising Junior or Rising Senior pursing a degree in Computer Science, Engineering, or related technical field. Indefinite right to work in the United States without the need for sponsorship now or in the future. Willing and able to relocate to Cambridge, MA for the co-op Ability to work independently and collaboratively. Ability to effectively collaborate in a dynamic, cross-functional matrix environment. Ability to thrive in a fast-paced, dynamic environment with a passion for continuous learning.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309255832229", "isPrivate": false}, {"id": 309256290563, "name": "Sr. Business Process Manager, Digital Quality", "location": "Norwood, Massachusetts", "locations": ["Norwood, Massachusetts"], "hot": 0, "department": "Digital", "business_unit": "Brad Miller", "t_update": 1701572809, "t_create": 1696377600, "ats_job_id": "R14449", "display_job_id": "R14449", "type": "ATS", "id_locale": "R14449-en", "job_description": "You are passionate about quality, continuous improvement, and enhancing systems to ensure optimal user experience and business efficiency. A master integrator gifted in bringing together people, concepts, and business goals with best-in-class execution. You thrive in a fast-paced environment and are comfortable rolling up your sleeves - if a process doesn't exist yet, you define it. You collaborate well amongst a team of expert peers. Bachelor's degree in science, technology, or another relevant academic discipline 8-10 years of experience designing implementing and maintaining electronic quality management systems to support compliance processes in a regulated biotech or Pharma company. Experience with GAMP and GxP compliance regulations Proficient in relevant project management software: Smartsheet, Excel, PowerPoint, Word, OneNote, MS Teams, etc. in addition to general knowledge with shared work environments Ability to manage multiple projects in a fast-paced environment. Ability to effectively collaborate in a dynamic, cross-functional matrix environment. Drive the execution of complex projects - proactively identifying risks / mitigation strategies while communicating to stakeholders and driving timelines through a blend of project management, technology, and business process expertise. Execute on our Digital Quality strategy with clear communication, prioritization, and escalation, both within Digital Quality and other cross functional teams Mentor a team of internal and external business analysts and software engineers designing, implementing, and maintaining our electronic quality management system, Veeva Quality Partner with digital stakeholders to ensure successful planning and integration of key systems into the quality management system while looking out for automation capabilities, and any artificial intelligence initiatives. Foster a culture of innovation within the team and with stakeholders to challenge the status quo leveraging both new technologies and creative solutions within existing systems. Support the Digital Quality Leadership Team by managing action plans and project plans to deliver short-, mid-, and long-term quality goals. Apply an operational excellence mindset to help Identify, devise, and recommend new opportunities to optimize current processes. Define and deliver a consistent systems governance methodology across applications with clear roles and responsibilities established throughout the system lifecycle: Implementation, Enhancement, and Support Ensure GxP compliance is built into the design, delivery, and maintenance of all systems. Maintain inspection readiness through adherence to internal quality policies, procedures, and training. Participate in internal and external audits as digital quality expert for portfolio of processes. Hit the ground running immediately and work closely with various stakeholders in Quality to enable sustainable commercial operations.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256290563", "isPrivate": false}, {"id": 309255646131, "name": "Director, Alliance Management, CDO Data and Digital Vendors", "location": "Cambridge, Massachusetts", "locations": ["Cambridge, Massachusetts"], "hot": 0, "department": "Corporate Development and Strategic Planning", "business_unit": "Stephen Hoge", "t_update": 1701570403, "t_create": 1694563200, "ats_job_id": "R14238", "display_job_id": "R14238", "type": "ATS", "id_locale": "R14238-en", "job_description": "Vendor Relationship Management: Develop and maintain strong relationships with CDO data and digital strategic vendors. Serve as the primary point of contact for all vendor-related matters, fostering open lines of communication and collaboration. Function as a liaison between internal stakeholders and external partners, facilitating communication, resolving conflicts, and promoting a healthy working relationship. Play a critical part in driving the success of strategic partnerships by ensuring compliance, promoting transparency, and fostering a culture of trust and collaboration among all parties involved. Strategic Partnership Governance: Develop, oversee, and manage the governance framework of strategic alliances, developing and implementing governance policies, procedures, and best practices to ensure effective collaboration and alignment among partners. Monitor and evaluate the performance of strategic partnerships, identifying areas for improvement, and implementing corrective measures when necessary. Contract Negotiation and Management: Collaborate with outsourcing, legal, and procurement teams to negotiate favorable terms and conditions for vendor agreements. Ensure compliance with contractual obligations and assist functional teams with monitoring performance metrics. Vendor Performance Monitoring: Establish and maintain performance metrics in conjunction with functional teams to evaluate vendor performance. Conduct regular performance reviews and provide feedback to vendors to drive continuous improvement. Collaboration and Alignment: Work closely with cross-functional teams to ensure effective collaboration with vendors. Align objectives, facilitate knowledge transfer, and drive joint initiatives to achieve mutual success. Issue Resolution: Proactively identify and address any issues or conflicts that may arise with vendors. Facilitate effective problem-solving and conflict resolution to maintain healthy and productive partnerships. Market and Competitive Analysis: Stay abreast of industry trends, market dynamics, and competitive landscape related to technical and software vendors. Provide insights and recommendations to internal stakeholders for strategic decision-making. Bachelor's degree in a relevant field (e.g., Healthcare, Science, Computer Science, Business Administration), advanced degree preferred or equivalent practical experience. Minimum of 10+ years of experience in the pharmaceutical or biotech industry, with at least 6 years of direct experience in alliance and/or vendor management, 2+ years of experience with data and digital vendors preferred. Proven experience in alliance management, vendor management, or partnership development within the technical/clinical development. Strong technical background and understanding of clinical development, software development processes, technologies, and trends. Excellent negotiation, contract management, and relationship-building skills. Exceptional communication and presentation abilities, with the capacity to effectively convey complex technical concepts to both technical and non-technical stakeholders. Strong analytical and critical thinking skills, with the ability to think strategically and drive results. Self-motivated, proactive, and able to work independently as well as in a collaborative environment. Demonstrated ability to manage multiple projects and priorities simultaneously, while meeting deadlines.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309255646131", "isPrivate": false}, {"id": 309256632033, "name": "Principal Product Manager - Digital Health", "location": "Cambridge, Massachusetts", "locations": ["Cambridge, Massachusetts"], "hot": 0, "department": "Digital", "business_unit": "Brad Miller", "t_update": 1701572351, "t_create": 1699401600, "ats_job_id": "R14662", "display_job_id": "R14662", "type": "ATS", "id_locale": "R14662-en", "job_description": "Define and drive product strategy Convert solution ideas into action through stories, mockups, and prototypes, bridging the gap between idea and product Launch new products and features, test their performance, and iterate quickly Partner closely with cross-functional teams to define and deliver on the next phase of cloud services Connect the technical and business worlds Break down complex problems into steps that drive product development Deeply understand the digital health and pharma ecosystem markets, competition, and user requirements Develop solutions to problems by collaborating as needed across regions, product areas, and functions Bachelor's degree in business, industrial engineering, or a field tied to the product sector OR 5 years of equivalent professional experience in lieu of a degree A minimum of 9 years of relevant job experience, with focus on digital health or pharma. 6+ years of experience in the software industry Experience working with cross-functional teams, including engineering, UX, Program management Experience working in an Agile SDLC with experience creating both functional and technical user stories Experience building and launching technology products and platforms at scale Experience building products from concept to production Experience working in life sciences, pharma/biotech Experience in developing software regulated under FDA / EMA Experience working in a matrixed organization", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256632033", "isPrivate": false}, {"id": 309256357925, "name": "2024 MBA Intern, Digital", "location": "Cambridge, Massachusetts", "locations": ["Cambridge, Massachusetts"], "hot": 0, "department": "Campus Programs", "business_unit": "Unknown", "t_update": 1701573369, "t_create": 1697414400, "ats_job_id": "R14536", "display_job_id": "R14536", "type": "ATS", "id_locale": "R14536-en", "job_description": "The Role: At Moderna, our mission is to deliver the greatest possible impact to people through mRNA medicines. Our singular focus is on using our mRNA platform and the innovative infrastructure we have built to deliver a new generation of transformative medicines for patients. Moderna is seeking MBA students to join the Digital team for our Summer 2024 MBA internship program. The Digital team provides comprehensive technology partnership to all facets of the organization - R&D, Clinical, Manufacturing, Commercial, and Corporate Functions. Our digital organization sets itself apart in the industry by leading with data science, artificial intelligence, innovation, and automation. We build our own solutions when we can do better than what's on the market and we integrate deeply with business groups to best understand stakeholder needs. Over the summer, our Digital MBA Interns will be exposed to a multitude of Digital workstreams and projects that play key roles in Moderna's ability to create transformative medicine for patients. The ideal Digital MBA Intern candidate draws from a broad base of prior pharmaceutical / biotech industry experience and is a self-starter who is excellent at navigating ambiguity. They have hands-on experience shipping new features/products/systems from requirements through to design, deploy, and run, radically improving an organization's ability to impact its customers in the process. Additionally, they are passionate about the role new technologies play in helping Moderna stay at the leading edge of biotech innovation for patients and are excited about the opportunity to make their mark in our dynamic environment. The Moderna MBA Programs: In addition to contributing to strategic projects on their teams, our MBA interns will have the opportunity to engage with our senior leaders, build lasting bonds with their cohort members, and participate in development opportunities that are unique to Moderna's innovative platform and culture. They will also gain insight into Moderna's MBA Leadership Accelerator Program, an 18-month program designed to develop Moderna's next generation of enterprise leaders. MBA interns who receive full-time offers after their internship would return to Moderna upon graduation as part of this exciting program. Timeline and Logistical Notes: The Summer 2024 MBA internship will be an 11-week experience running from June 3 - Aug 16, 2024. (Any changes to internship dates will be communicated to students during interviews). The application deadline for the internship is December 5th, 2023 and applicants will be invited for interviews by mid-December. Interviews will be conducted in early/mid-January and successful candidates will be notified by the end of January. Moderna has posted separate job postings for each business function's MBA intern roles. Eligible students are welcome to apply to as many of these postings as they would like but will only be invited to interview for a maximum of two different MBA intern roles. Here's What You'll Need (Minimum Qualifications): Currently enrolled as a 1st year in a full-time MBA program (planned graduation in Spring 2025) 5+ years experience pre-MBA in big tech, pharma information technology, or other technology-focused company as a developer, program manager, product manager, or comparable role. Here's What You'll Bring to the Table (Preferred Qualifications): Significant experience building, standing up, and/or radically improving enterprise technology solutions or technology products that drive an organization's ability to achieve its mission Proven passion for exploring and driving the meaningful application and adoption of cutting-edge technologies within an organization (AI/ML-specific experience is a plus) Proven experience successfully delivering on initiatives with complex business deliverables and cross-functional stakeholder engagement requirements Advanced verbal and written communication skills; ability to effectively translate technical information into compelling narratives and facilitate meaningful conversations with senior stakeholders across the business Ability to multitask, learn quickly, and pivot fearlessly based on real-time data Comfort with ambiguity and with designing and executing projects simultaneously Commitment to learning about the science behind our mRNA platform technology, ideally grounded in academic or professional experience with a discipline related to drug discovery and development (e.g., biology, chemistry, biochemistry, molecular biology) Strong business acumen, analytical skills, demonstrated success with cross-functional collaboration, and a high EQ Desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative Moderna is pleased to provide you with an innovative suite of benefits, including: Free premium access to meditation and mindfulness classes Free parking or subsidized commuter passes Generous paid time off, including: Vacation, sick time and holidays Volunteer time to participate within your community Discretionary year-end shutdown Location-specific perks and extras! 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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