About the job
External Manufacturing GenMed Europe (EM GenMed EU) Quality & Regulatory department is the quality unit responsible for GxP oversight of Contract Manufacturing Organizations (CMOs) and business partners involved in the manufacture, testing, and transport of Sanofi products. External Manufacturing CMO Quality Oversight, External Manufacturing Quality Processes and CMOs portfolio Regulatory activities for Europe perimeter.
EM GenMed Europe staff interacts with functional units within External Manufacturing Global, Global Quality, Sanofi sites, and other organizations within the industrial 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.
Under the supervision of External Manufacturing Quality & Compliance Head, the incumbent will be responsible for:
- Securing Quality of outsourced activities and provides guidance to operational teams to manage quality oversight of a portfolio of CMOs, including management of quality events, risk management, change control management, Product Quality review, Complaints, Audits & inspection, CMO documentation review and approval when appropriate,
- Managing the Sanofi CMO Quality team for the concerned CMOs, providing leadership, guidance, support, and direction to the team consistent with cGMP and company corporate quality governance
- Operating as Quality spokesperson for Sanofi in front of CMOs, notably during Quality Reviews with CMOs,
- Ensuring the quality issues are managed properly and evaluate the CMO decision regarding the final disposition of impacted batch(es) and confirm the Sanofi decision to the CMO,
- Identifying reactive & pro-active risks and track them through the defined process. Define and track associated actions to mitigate these risks. Escalate any critical issue according to defined escalation process,
- Identifying opportunities and positive changes to improve quality assurance processes and practices,
- Ensuring oversight and expertise of Product Quality Review process for External Manufacturing Europe portfolio
- Ensuring oversight and expertise of Product Complaint management for External Manufacturing Europe portfolio,
- Ensuring effective interactions with internal departments (Regulatory team, other External Manufacturing Quality teams, Supply chain, Global Quality functions, …),
- Experience: Extensive Quality Assurance and Quality Control experience, including experience in a pharmaceutical manufacturing site and previous experience in External suppliers/contractors’ management
- Soft skills:
- Ability to work in a matrix organization.
- Strong interpersonal and communication skills with excellent command of English.
- Strong network abilities: interactions with multiple functions across the organization as well as with external providers and partners.
- Leadership and assertiveness skills,
- Decision making, takes initiative and is pro-active
- Ability to identify situations and issues which need escalation to line management
- Technical skills: Excellent cGMP knowledge, In-depth knowledge of Pharmaceutical Operations, Qualification as external auditor is a plus
- Education: Bachelor’s or advanced degree (e.g., Master, PhD or equivalent) in life sciences or related fields
- Languages: English spoken and written compulsory, with other languages welcomed (French is an asset)
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