Specialist* IMP GxP Compliance
- Work experience
- Project Management, Product Management
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.
Specialist* IMP GxP Compliance
Your main responsibilities are:
- Support GCP compliance of all clinical trial supply management and drug-related activities in global Phase I-III clinical trials from drug product manufacture to on site disposal. This does include contribution to set-up and optimization of process and workflows
- Responsible for project-related/project-independent GCP and GMP documentation and filing thereof, maintenance of lists
- Operational support and independent performance of GxP related operational tasks as process expert across diverse clinical trials and R&D Programs including deviation, change and CAPA management (e.g., Pharmacy Manuals, Pharmacy Questionnaires, TMF Filing)
- Support management of vendors and strategic alliances (e.g. CROs, Pharmacies, Sites) e.g. Training on requirements, issue solving, alignment on timelines and processes including harmonization
- Involved in establishing and maintaining inspection readiness for clinical trial supply activities under BNT`s responsibility (Action Tracker, training status, filing, deviations, changes, CAPAs, etc.). This does include support in preparing, accompanying and following up on internal and external audits/inspections (collaboration partners, competent authorities; GCP and GMP)
What you have to offer.
- Successfully completed vocational training or bachelor degree with focus on clinical trial management or comparable qualification
- Several years of professional experience within clinical trial supply management in the GxP-regulated environment of the pharmaceutical industry
- GCP background would be beneficial
- Excellent analytical, communication and problem solving skills
- Ability to work in a rapidly changing environment with dynamic targets and expanding processes, excellent organizational and communicative skills, independent, reliable and pro-active way of working
- Business-fluent English is a must, German skills are a plus
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, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).
Job-ID 4999 (please indicate for inquiries)
We look forward to your application!
*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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