QA Operations Head / Resp. AQ des opérations

Sep 09, 2021

Job Description

Have you ever heard of CAR-T cells? CAR-T cell therapy is a new type of immunotherapy based on innovative technology and is currently being widely developed to treat certain cancers. Our plant at Les Ulis, near Paris, is the leading CAR-T production facility in France.

Your Responsibilities Will Include But Are Not Limited To:
- Leadership of team of >30 associates. Leadership of several teams within QA Ops operations
-Ensure compliance to cGxP standards for products within Cell and Gene Therapy manufacturing and testing site (during development, transfer and commercialization) and product release.
- Operational excellence
- Provide guidance, support and leadership to teams within area of responsibility.

Major accountabilities:
• Ensure QC and manufacturing activities executed according to cGxP standards
Ensure aseptic oversight
• Collaboration in GxP audits/inspections
• Oversight of Quality Operations across site
• MBR review and approval
• Product release
• QA for Quality Control & AS & T
• QA Operational Excellence

Minimum Requirements

Relevant Experience
- Several years of experience (> 10 years) in the release of medicinal products for human use, manufacturing and/or QC testing; several years of experience of leading a large team
-Preferable experience in aseptics, Cell and Gene and/or biologic operations
- Functional Breadth; People Leadership; Organization Scope; Scale and Complexity; Collaborating across boundaries; Project Management

Education & Qualification
- University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
- Qualified Person (depending on local requirements)

Fluent (oral and written) in English; preferable good in local language (oral and written)
Novartis Technical Operations
Temps plein
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QA Operations Head / Resp. AQ des opérations

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