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QA Manager (CMO)
Job description
A leading pharmaceutical company is seeking a Quality Assurance Manager (CMO) to oversee the quality management of contract manufacturers. This is a confidential opportunity to join a fast-growing, internationally focused organization and play a key role in ensuring regulatory compliance and operational excellence.
This role will offer you:
- Work on cutting-edge pharmaceutical projects with a global impact.
- Join a company with a strong commitment to innovation and quality.
- Competitive package and opportunities for career growth.
Key Responsibilities:
- Ensure contract manufacturers comply with EU-GMP, international guidelines, and internal quality standards.
- Conduct GLP & GMP audits, prepare reports, and oversee corrective actions.
- Manage deviations, CAPAs, laboratory investigations, and customer complaints.
- Support QC method transfers, validations, and process technology transfers to new production sites.
- Review batch documentation to ensure compliance with regulatory and company standards.
- Maintain and improve quality management systems (QMS), conducting internal audits and risk assessments.
- Evaluate and coordinate product changes to ensure compliance with registration requirements.
- Manage supplier evaluations and oversee annual product quality reviews (PQRs).
- Monitor QC analytical results and support batch release recommendations.
Your Profile:
- MSc degree in Life Sciences (Pharmacy, Biology, Chemistry, or related field).
- 5+ years of experience in GLP, GMP, and GDP within the pharmaceutical industry.
- Basic knowledge of Regulatory Affairs.
- Fluent in German and English (business proficiency).
- Strong team player with excellent communication skills.
- Willingness to travel within Europe and Asia.