Commissioning and Qualification Manager
Listed on 2025-12-22
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Quality Assurance - QA/QC
Quality Engineering
Job Title: Commissioning and Qualification Manager
Location: Framingham, MA
About the JobJoin a global network that powers how Sanofi delivers — seamlessly, purposefully, and Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.
About SanofiWe’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main Responsibilities- Lead the Process, Plant & CQ team and ensure sufficient resources available for all process, plant & CQ activities based on site needs and strategic workforce planning
- Leads investigations & develops CAPAs for unplanned disruptions, breakdowns and deviations
- Identify improvement opportunities for critical systems
- Act as an SME for an quality related discussions during audits/inspections and provide support to Capital Projects as required
- Implementing process improvements to enhance efficiency, safety, and quality.
- Participate in applicable COPs
- BS - Engineering, Life Sciences or related discipline - preferred. A combination of education and experience will be considered.
- 5+ years of experience in GMP regulated environments.
- Extensive knowledge of regulatory requirements for CQ activities and be able to defend and justify CQ plans and practices during internal/external audits.
- Strong People Management skills and demonstrated ability to work with cross functional teams
- Technical writing and investigation techniques
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, domestic partnership or civil union status, sex, gender, gender identity or expression, sexual orientation, disability, veteran or military status or any other characteristic protected by law.
The salary range for this position is: $ - $. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the link.
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