Job Title: Manager, Quality Operations – Vaccine
📍 Location: Waltham, Massachusetts, USA
💰 Salary Range: USD 108,750 – 181,250
About Sanofi
Every day, Sanofi delivers over 2.5 million vaccine doses worldwide — powered by bold ideas, cutting-edge science, and passionate professionals. From discovery to delivery, Sanofians are shaping the future of vaccines through innovation, collaboration, and a shared mission to protect global health.
We are a global healthcare company committed to helping the world stay ahead of infectious diseases, delivering over 500 million vaccine doses annually to millions of patients worldwide.
About the Job
The Manager, Quality Operations ensures compliance with Sanofi’s Standard Operating Procedures (SOPs) and current industry standards (cGMPs) throughout product development.
This role provides leadership to the Operational Quality team and influences the overall quality mindset within the organization, reporting directly to the Head of Quality.
Main Responsibilities
Quality Systems & Compliance
Develop and implement phase-appropriate Quality Assurance (QA) systems and strategies.
Maintain compliance with US, EU, and ICH GMP standards for manufacturing, testing, and stability programs.
Lead review and approval of master production records, in-process and release testing, and specifications.
Serve as QA representative for all execution documentation and stability programs.
External Manufacturing Oversight
Ensure quality oversight for external manufacturing of Lipids, Enzymes, pDNA, and Master Cell Banks.
Manage Quality-to-Quality relationships with CDMOs, including visits and participation in project teams.
Align quality systems between Waltham and France CoE sites to ensure harmonized operational excellence.
Governance & CAPA Management
Establish and monitor Quality KPIs, metrics, and compliance reports.
Oversee Deviation/Investigation, CAPA, and Change Control processes.
Support and improve Inspection Readiness and Audit programs (internal/external).
Strategic Leadership
Collaborate with cross-functional teams on discovery, development, and operational projects.
Communicate key quality risks and updates to senior management.
Participate in the development of Quality Technical Agreements, contracts, and SOWs.
Promote a risk-based, innovation-driven quality culture within GxP operations.
Team Development
Coach, mentor, and motivate the Quality Operations team to achieve operational excellence.
Foster high performance, accountability, and continuous improvement.
Communicate KPIs and company goals clearly to align team objectives.
About You
Education
Bachelor’s degree (required) in STEM (Science, Technology, Engineering, Mathematics).
Master’s degree preferred.
Experience
12+ years in the pharmaceutical/biotech industry with 10+ years in Quality functions (QA preferred).
Strong understanding of GMP compliance, regulatory inspections, and submission documentation.
Experience in outsourced manufacturing/testing (CDMOs).
Proven track record of implementing Operational Excellence initiatives.
Skills
Excellent leadership and decision-making abilities.
Strong communication, negotiation, and cross-functional collaboration skills.
Data analysis, reporting, and trending expertise.
Self-motivated, detail-oriented, and effective time management.
Demonstrated ethical conduct and sound judgment.
Why Choose Sanofi
🌍 Join a future-focused global leader bringing the miracles of science to life.
💼 Explore career growth opportunities through promotions or international mobility.
💎 Receive a competitive rewards package recognizing your contributions.
👨👩👧 Enjoy comprehensive healthcare, wellness programs, and 14 weeks of gender-neutral parental leave.
🤝 Work in a diverse and inclusive environment, guided by equal opportunity principles.
Equal Opportunity Statement
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers.
We celebrate diversity and provide equal opportunities to all applicants regardless of race, color, religion, gender, age, sexual orientation, disability, veteran status, or other protected characteristics.
Tags
#QualityOperations #GMP #VaccineManufacturing #PharmaceuticalQuality #OperationalExcellence
#GD-SP #LI-SP #LI-Onsite #vhd
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