Post-release Quality Manager

About the job:

Our Team:

External Manufacturing General Medicine 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 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 Affiliates, 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.

Main responsibilities:

Under the supervision of the EM GenMed EU CMO Quality Management & Post-release Head, the incumbent will be responsible for:

Product Quality Review:

• Manage defined PQRs portfolio evaluation
• Review the PQR and escalate issues if necessary
• Track the planning and make action towards CMO in case of delay

Product complaint:

• Coordinate the reception of market complaints and the investigation with the CMO
• Ensure the answer to complaint in the defined timelines
• Identify the complaint that need to be escalated and coordinate actions with the CMO Quality team for escalation

Other:

• Participate on preparation of Site Quality review, Business reviews with CMOs
• Accountable for ad-hoc project completions and achievement of compliance goals
• Ensure effective interaction with other external & internal departments on matters related to investigation or issue
• Perform CMO audit as defined (if qualified as auditor)

About you:

Experience: Previous QA and/or QC experience, including experience in a pharmaceutical manufacturing site and/or previous experience in CMO quality management
Soft skills:Ability to work in a matrix organization. Strong interpersonal and communication skills (writing & verbal) with excellent command of English.
Decision making
Attention to detail
Good organizational skills
Ability to identify situations and issues which need escalation to line management
Technical skills: Demonstrated cGMP knowledge, In-depth knowledge of Pharmaceutical Operations, Knowledge of MS Word, MS Excel, MS PowerPoint, MS Outlook
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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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, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.