QA Manager - Biotech

You manage the quality follow up of this first marketed product as well as Investigational Medicinal Products (IMP), collaborating with the Pharmaceutical Operations Unit.

For the projects that you manage:

• You perform subcontractors audits for assessing and controlling GMP compliance and other applicable guidelines for the whole externalised activity, from API manufacturing to final product labeling, storage and distribution, for commercial batches or clinical ones
• You write Quality Agreements
• You take part to project meetings
• You manage associated deviations to manufacturing activities as well as change control
• You verify the documents (batch records, certificates of analysis) produced by the subcontractors and file them according to the Document system.
• You participate to the structure of the company for launching the product on the market (procedure writing)

For the whole pharmaceutical activity

• You perform internal process audits for ensuring GMP and Quality System compliance of activities related to Vendors and supply chain control, pharmaceutical development, product specifications, stability studies…
• You verify and files documents issued from the previous activities
• You verify quality documents (procedures, instructions)
• You participate to investigations related to claims or recalls
• You do regulatory watch and subsequent actions
• You contribute to continuous improvement

Skill

• Scientific degree or pharmacist completed with a quality training
• Strong GMP knowledge
• Experience with Biologic medicinal products
• External audits
• Ability to work in French and in English, written and spoken
• 8 years’ experience in pharmaceutical industry

Soft skill

• Team spirit and collective intelligence
• Autonomy and dynamism