QA Manager (CMO)

Business Manager, Key Account Management at BioTalent part of the IN Group

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.