Senior Quality Assurance Manager (GLP) | Chemiker (m/w/d)
A&M Labor GmbH
Job Summary
This is a pivotal leadership role within a specialized bioanalytical contract research organization (CRO) based near Cologne. As the Senior Quality Assurance Manager, you will hold strategic and operational responsibility for the company's GLP-compliant Quality Management System (QMS). Your daily activities will include planning and conducting internal inspections, managing supplier audits, and serving as the primary point of contact for regulatory authorities and client inspections. You will play a critical role in reviewing essential documents such as SOPs and study reports, while advising laboratory management on GLP compliance and data integrity. This part-time position (minimum 25 hours/week) offers significant creative freedom and a direct line to executive leadership. It is an ideal opportunity for a seasoned professional looking to shape quality processes in a high-stakes pharmaceutical environment while maintaining a flexible work-life balance through mobile work options and flexible scheduling.
Required Skills
Education
University degree in natural sciences (e.g., Chemistry, Pharmacy, or Biology) or a completed technical/pharmaceutical vocational training with equivalent professional experience.
Experience
- Minimum 10 years of experience in GxP Quality Assurance
- Extensive experience in GLP-regulated analytical or laboratory environments
- Proven track rate in implementing and maintaining QM systems
- Demonstrated experience in managing inspections by authorities and clients
- Professional experience in handling deviations, CAPAs, and change control processes
Languages
Additional
- The role is a part-time position with a minimum of 25 hours per week, with potential for future increases. Location is Bergheim, Germany, with options for mobile work. Candidates must have extensive knowledge of OECD GLP guidelines.