Quality Assurance Manager

NeuchâtelFixeChimie, Pharma, Biotechnologie2019-06-21Non exigé / Non qualifié
Spring Life Sciences is looking for his client a

Quality Assurance Manager

Responsabilities:

• Manage, lead and coach the Quality Assurance System team.
• Ensure conformity and application of the Quality Management Systems across the facility.
• Manage customer audits and regulatory inspections.
• Drive strategies to continuously improve Quality Management Systems
• Collaborate actively with the business partners to develop quality mindset.
• Monitor the foreseen regulatory evolutions to anticipate new requirements and get set for the future.

Profile:

• Educational background in Biology, Pharmaceutical or related domain (BSc/MSc or equivalent education in Science).
• At least 5 years of experience in Quality Assurance in an In Vitro Diagnostics company or other related industry (Pharmaceutical, Biotechnology, Medical); including 3 years in a management role.
• Thorough understanding of ISO Norm 13485, the European
• Directive 98/79/CE and IVDR and the 21CFR820.
• Strong leadership, people management and coaching skills.
• Excellent team player with a strong ability to communicate within a multicultural environment, at all organizational levels, and with regulatory representatives
• Strong problem solving skills, with creative and strategic thinking.
• Experience with project management, experience in Lean or Six
• Sigma projects preferred. Certification Lean / 6 σ Green Belt would be a plus.
• Either French or German as a native language, with good knowledge of the other language. English on a professional level

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