Associate Director Clinical QA Compliance ensuring quality and integrity of clinical development activities at BioNTech. Leading the proactive, risk - based Quality Strategy implementation across clinical trials.
About the role
- QA Professional responsible for quality assurance in pharmaceutical logistics. Supporting audits and managing quality documentation at the Rosengarten site in Germany.
Responsibilities
- Support for qualification and validation activities within a GDP environment
- Local document management including creation, maintenance, and administration of quality documents
- Local QA contact for operational units
- Responsibility for local deviation management
- Participation in QA projects
- Preparation of quality-related documents (SOPs, qualification documentation, CAPA, change control) in German and English
- Support in the implementation of new clients at the site
- Conducting initial and refresher training in GDP
- Responsible for local change control processes
- Oversight and monitoring of automated temperature monitoring systems
Requirements
- University degree in natural sciences or engineering (e.g., biosciences, pharmacy, chemistry, medical engineering, biotechnology) or an equivalent qualification
- Alternatively: completed vocational training in the pharmaceutical sector or comparable, with long-term professional experience and/or further qualifications in GDP/GMP quality management
- Relevant professional experience in quality assurance (GDP or medical devices), preferably in pharmaceutical wholesale
- Sound knowledge of regulatory requirements in the pharmaceutical environment
- Experience in pharmaceutical quality assurance (GDP and/or GMP) is essential
- Fluent German (C2) and very good English (at least C1) in spoken and written form
Benefits
- Personal development: We support your professional growth through training in relevant and other interesting topics
- Flexible work arrangement: After completion of onboarding, the option to work remotely up to two days per week
- Vacation: 30 days of annual leave per year
- Financial security: Employer contribution to the company pension scheme and company disability insurance
- Additional benefits: Employee discounts via Corporate Benefits, company bike leasing through JobRad, Wellpass, Nilo Health, and employee parking
Job title
Job type
Experience level
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Not specified
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Location requirements
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