Mainz, Germany | full time | Job ID: 9951
Your Main Responsibilities:
· Supervise a team developing, improving and implementing QC processes globally ensuring digitization strategy for central QC processes
· Act as Head of Quality Control as per German AMWHV and assure compliance with German and international regulations
· Lead strategy development and align between the local QC-teams working on digitalization and digital operations and Aat as central QC-interface towards centalized IT-functions and business owners representing all QC sites
· Stakeholder management of internal departments, authorities as well as external partners
· Review and approve QC relevant strategic documents and drive centralized operational processes (e.g. shelf life extension)
What You Have to Offer:
· 10+ years experience in GMP Quality Control, including at least 5 years as QC Head or equivalent leadership role in the pharmaceutical or biopharmaceutical industry, with a proven track record of success
· In-depth experience with digital systems within Quality Control, including QC-LIMS systems (e.g., LabWare); SAP experience is a plus. Strong expertise in computer system validation and strategy development for digital system implementation
· Proven ability to implement and manage globally harmonized systems, KPIs, and processes while driving alignment between multiple QC sites to ensure lean, compliant, and scalable analytics
· Demonstrated leadership skills with strong stakeholder management abilities and the capability to represent QC interests at senior management level
· Extensive experience managing audits and inspections, including successful interactions with regulatory authorities such as the FDA. Strong knowledge of country-specific regulations and global regulatory frameworks ensuring compliance across multiple regions
· Fluent in English (written and spoken); German is a plus
Your Benefits:
It's our priority to support you:
Apply now - We look forward to your application!
Apply to our Mainz, Germanylocation by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).
Job ID 9951 (please always specify if you have any questions)
By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
Biopharmaceutical New Technologies (BioNTech) is a global biotechnology company aspiring to translate science into survival by developing new immunotherapies utilizing the full potential of the immune system to fight cancer and infectious diseases.
BioNTech is headquartered in Mainz, Germany, and operates globally with almost 7.000 pioneers. Our work is powered by one mission: Improving the health of people worldwide. We believe that scientific rigor and passion are the driving forces that are essential for innovative progress.
BioNTech was founded in 2008 by scientists and physicians to translate science into survival by combining fundamental research and operational excellence. At BioNTech, we have been conducting fundamental research of mRNA technologies in the field of individualized cancer medicine for more than a decade. Some of our colleagues, including our co-founders, have been researching and developing mRNA-based vaccines for more than 25 years.
Ready to join us on this journey? Explore the opportunities and become part of a team that aspires to turn bold ideas into real-world solutions: https://www.biontech.com/int/en/home/careers.html
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