QA Manager (CMO)

Posted 30 January 2025
Salary 70,000-80,000 EUR
LocationAachen
Job type Permanent
Discipline Quality
Reference210479
Contact NameNatasha Cole

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.