About this role
Role Overview
- 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