Manager* AS&T Compliance
- Work experience
- Quality Management, Quality Assurance
Become a member of the BioNTech Family!
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
Manager* AS&T Compliance
Your main responsibilities will be:
- Developing, executing and implementing a robust GMP compliant system for AS&T or all relevant GMP and regulatory documents within the network of external laboratories and Contract Manufacturing Organizations (CMOs)
- Ensuring the GMP-compliant release of commercialized medicinal products as well as investigational medicinal products for pivotal studies of BioNTech as Marketing Authorization Holder and sponsor
- Coordinating and monitoring changes, deviations, corrective measures within the AS&T and Quality Control (QC) network for the GMP-compliant testing of commercial drugs, working jointly together with the Operational Quality Assurance (OQA) Single Point of Contacts
- Overseeing and evaluating regulatory approval-relevant changes and mapping of external change control systems from labs and CMOs, and ensuring that updates in regulations are implemented in analytical methods
- Providing support for troubleshooting and continuous improvement in the laboratory
What you have to offer.
- University degree in Life Science/Healthcare
- Several years of work experience in quality compliance governance within the life science industry (ideally a biotech or pharmaceutical company)
- Deep expertise of relevant US and EU, EMA, FDA regulatory standards, and Good Manufacturing Practice
- Good understanding of quality compliance management obligations, requirements and dynamics, as well as good knowledge of the QC release process
- Very good communication skills, fluency in German and English
- High team spirit, excellent collaborating skills, and effective stakeholder management skills
- High conscientiousness and detail-orientation
Benefits for you.
- Company Pension Scheme
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation
Have we kindled your pioneering spirit?
If you have any further questions, Johanna Diehl will be happy to answer them on + 49 (0) 6131-9084-1291 (Monday - Friday, from 12 noon).
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!
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