External Manufacturing and Supply Operational Quality Manager, Management of Contract Manufacturing Organization

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Your job, as External Manufacturing and Supply Operational Quality Manager, Management of Contract Manufacturing Organization within our General Medicines and Vaccines team, will be to interact with functional units within General Medicines Large Molecules and Vaccines Quality, Specialty Care Quality (SCQ), Sanofi sites, and other organizations within the Specialty Care network (e.g. procurement, supply chain, finance) to ensure compliance with internal and regulatory requirements, and to disposition intermediate (e.g. API, drug substance) and finished products with minimal risk to quality or product supply.

• The Quality Assurance Manager is the responsible Quality point of contact for the Contract Manufacturing Organization (CMO), providing direct support from a quality and compliance perspective.
  
• The Quality Assurance Manager coordinates oversight of all quality interactions with the Contract Manufacturing Organization (CMO) and serves as the quality representative in both internal core team meetings and joint meetings with the Contract Manufacturing Organization (CMO).
  
• The role is responsible to ensure cGMP documents and records obtain and meet expectations for the required Sanofi review and approval in accordance with Sanofi procedures and guidelines.
  

• Act as Contract Manufacturing Organization (CMO) Quality site contact and responsible for Contract Manufacturing Organization (CMO) quality oversight
  
• Quality representative actively engaged in internal core team meetings and joint meetings with the Contract Manufacturing Organizations (CMOs).
  
• Responsible for quality oversight of cGMP documents and records (includes but not limited to: batch production records, validation protocols/reports, product release documentation, change controls, deviations, CAPA, lab investigations, complaint investigations, product quality review, quality agreements, product technical specifications).
  
• Monitor contractor performance to established key performance indicators (KPI) and report and escalate adverse trends
  
• Ensure adequate remediation plan to improve key performance indicators (KPI) as well as risk ranking outcome.
  
• Demonstrate understanding of applicable health authority regulations related to manufacture of medicinal products (small molecules and biologics).
  

• Bachelor's degree and 10+ years of experience working in a cGxP or other regulated environment, with 3+ years of experience in a Quality role.
  
• 2 - 5 years supervisory and/or management experience.
  
• Familiarity with global cGMP and ISO regulations relating to medicinal products; strong understanding of principles, concepts, practice and standards for Quality Assurance function.
  
• Experience with data analysis, trending, and presenting material within multi-functional environment.
  
• Demonstrated ability to perform work that consistently requires independent decision making and the exercise of independent judgment and discretion.
  
• Excellent communication and negotiation skills.
  
• The ability to excel in a highly matrixed organization.
  
• Ability to support Person in Plant at a local CMO is required.
  

• 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.