European Quality & CMO Management Lead (m/f/d)

• Lead the vendor and CMO management processes with an emphasis on compliance and excellence.
• Coordinate the preparation and execution of audits and inspections, along with the follow-up actions.
• Execute annual Product Quality Reviews and effectively address complaints.
• Oversee quality assurance activities on a European scale.
• Promote close cooperation and active communication within the team and with external partners.

• Significant experience in the bio-tech/pharmaceutical manufacturing industry.
• Deep knowledge of position-relevant regulations (EU GMP & EU GDP).
• Experience within a QA/QC/GxP regulated environment, preferably in the Biotechnology/Pharmaceutical Industry.
• Proven ability in qualifying new critical suppliers related to medicines and conducting EU GMP audits for suppliers and contract manufacturers/packers inside and outside the EU, including third countries.
• Experience in contributing to annual Product Quality Reviews and complaint evaluations.
• Experience with audits.
• CMO/Vendor Management experience.
• Strong communication skills and the ability to collaborate effectively both internally and externally.
• Team Leadership experience with the ability to manage large teams effectively
• Proficiency in English required; proficiency in German is desirable

• A critical role in the mission to deliver high-quality products to help patients globally.
• A company ethos that recognises your expertise and supports your professional growth.
• Competitive compensation, benefits, and a team-oriented work environment.

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