Director* Operation Quality Assurance - Strategic Partnerships East Asia
- Senior, very experienced
- 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.
Director* Operational Quality Assurance - Strategic Partnerships East Asia
Your main responsibilities will be:
- Executing the transfer of QA-specific knowhow during the product implementation / transfer to a new manufacturing site and during the production phase
- Supporting on upcoming quality topics, e.g. deviations (Provide input, create contact to experts, follow up on actions, etc.)
- Leading regular / attend irregular meetings with joint venture partners (incl. preparation, agenda, minutes, follow up on actions, etc.)
- Supporting the GMP-compliant implementation and improvement of quality management at joint ventures, including the establishing and monitoring of KPIs
- Reviewing and approving documentation regarding the joint ventures to assure GMP-compliance
What you have to offer.
- University degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area
- Multiple years of work experience in quality assurance, quality oversight or relevant experience, ideally in a biotech or pharmaceutical company
- Experience managing work in both team setting and independently
- Profound knowledge of relevant Chinese, US & EU regulations, EMA, FDA, NMPA, and other regulatory standards as well as Good Manufacturing Practice
- Effective collaboration, coordination and stakeholder management skills, both in cross-functional internal and external matrix team environment
- Good combination of strategic and operational skills; ability to make flexible, but thorough decisions in a highly dynamic environment
- High carefulness and accuracy in the way of working, conscientiousness and detail-orientation
- Refined colloquial and correspondence skills in both German and English; presentation skills adaptable to all levels of internal and external stakeholders
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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