Job Title: Senior Quality Assurance Specialist BioDP

About the Job

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

The purpose of this position is to provide quality oversight of Sanofi sponsored GMP manufacturing and testing of Biologics drug products and genomic medicines at the clinical injectables manufacturing (CIM) operation, third parties (Contract Manufacturing Organizations (CMOs), and oversight of BioAnalytics or clinical laboratory operations (CLOs). The primary responsibility of this position is to perform lot disposition activities for United States and follow-on clinical markets. The responsibility is significant for ensuring safety, integrity, strength, purity, and quality (SISPQ) for clinical patients. For some clinical programs, the manufacturing process may not yet be locked requiring quality decisions to be made using phase-appropriate GMP principles coupled with quality risk management (ICH Q9).

About Sanofi:

We’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:

• Compile all batch-related documentation and identify any potential risk to SISPQ followed by the appropriate mitigation prior to release. Complete the release process within the appropriate ERP system

• Assist with all quality operational activities between Sanofi and external partners to maintain GMP compliance. External partners include Contract Manufacturing Organization (CMOs) and/or Contract Laboratory Organizations (CLOs)

• Identify, communicate, and mitigate quality risks in a proactive and collaborative manner maintaining the business interests of Sanofi and consideration of suitable outcome for the projects

• Report progress, status, and risks associated with projects, including recommending and implementing solutions/corrective actions

• Ensure timely review of all GMP documents (batch records/analytical specifications, data, validation protocols/reports, COAs, deviations, change controls, etc.) is in alignment with quality and regulatory expectations prior to release and/or approval. This may also mean facilitating the documentation package in collaboration with Qualified Persons (QP) for releases in Europe

• Participate or lead investigation of all batch associated deviations, risk assessments, and change controls in compliance with SOPs and company policies

• Act as GQO Project Team Representative in CMC meetings for assigned project(s)

• Promote Quality excellence and Quality Culture as a Quality Culture Liaison

• Provide real time Quality input to enable effective, compliant solutions to emerging issues within the and CIM and BioAnalytical teams

• Ensuring all processes and products meet specified standards

• Lead and support the drive for consistency and continuous improvement efforts

• Provide Quality oversight on bulk shipments activities including samples and Master Cell banks

• Provide technical expertise and high-level decision making across the site to review and approve quality and technical documentation including deviations, CAPAs, Change Controls and effectiveness reviews as well as associated documentations with Preventive/Corrective Maintenance, Metrology, Engineering and Validation Protocols

• Ensuring all compliance requirements are met on day-to-day operations while effectively communicating compliance requirements and making decisions that uphold ethical standards

• Continuously improve processes to enhance quality

About You

Basic Qualifications:

• B.S. or B.A. degree, preferably in one of the areas of pharmaceutical drug development (e.g., Engineering, Pharmacy, Chemistry, Biochemistry, Biotechnology, or closely related discipline) but will consider all degrees.

• 3+ years’ experience working within Pharmaceutical or Biopharmaceutical industry.

• Strong background and knowledge of cGMP / ICH / FDA / EMA regulations, (including specific regulations and guidance for DP manufacturing), Chemistry Manufacturing Controls (CMC) required by health authorities and preparation/review of regulatory dossiers and interactions.

• Technical writing and good verbal communication skills, plus ability to influence at all levels across internal and external network including Development, Manufacturing, Engineering, Digital, Quality, Procurement, and Regulatory Affairs.

• Change agent with Project Management experience in a complex environment, dealing with leading international and/or multi-cultural teams.

• Technical skills: prior experience in Research & Development activities and processes (specifically in a CMC-related field).

Preferred:

• M.S. degree preferred but not required

• French or German speaking is a plus!

Why Choose Us?

• 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, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

North America Applicants Only

The salary range for this position is:

$90,000.00 - $130,000.00

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.