Senior Quality Assurance Specialist BioDP

Job Title: Senior Quality Assurance Specialist BioDP

Location: Framingham, MA

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 / F