Organize and manage central quality processes such as the CAPA system, SOP management and other QA-relevant workflows
Independently handle deviations and change control processes and ensure efficient follow-up
Plan and conduct audits, subcontractor audits and supplier qualifications autonomously
Lead projects within the quality department and contribute specialist expertise to cross-functional initiatives
Support the role of the person responsible under § 52a of the German Medicines Act (AMG) and deputize for them if appropriately qualified
Oversee the QA system within a collaborative European partner network
Requirements
Degree in natural sciences or engineering (e.g., biosciences, pharmacy, chemistry, medical technology, biotechnology) or an equivalent qualification
Alternatively, completed vocational training supplemented by many years of professional experience and relevant further qualifications in the pharmaceutical industry and in quality assurance
Solid professional experience in quality management under GDP/GMP guidelines or in the medical device environment
Ideally have conducted audits and hold auditor qualification
Experienced in preparing quality-relevant documents such as SOPs, audit reports as well as CAPA and change-control documentation — proficient in German and English
Very good German skills (at least C1) and good English skills (at least B2/C1)
Benefits
Personal development: We support your professional growth through training in relevant and other interesting topics
Flexible workplace: After completion of onboarding, up to two days of home office per week are possible
Vacation: 30 days of vacation per year
Benefits for security: Employer contributions to company pension scheme and occupational disability insurance
Additional benefits: employee discounts via Corporate Benefits — bike leasing via Jobrad — Wellpass — Nilo Health — employee parking