Director QC Digitalization Strategy | Biologe (m/w/d)
BioNTech SE
Job Summary
This senior leadership role focuses on driving the Quality Control (QC) digitalization strategy across multiple sites within the pharmaceutical or biopharmaceutical network. The Director will lead strategy development, ensure alignment among local QC teams regarding digital operations, and serve as the central QC interface to centralized IT functions and business owners. A core function involves rigorous stakeholder management, including internal departments, regulatory authorities, and external partners. Key daily activities include developing, reviewing, and challenging QC-relevant processes across the network, and approving crucial strategic documents. Candidates must bring 7+ years of experience in the GMP environment, deep expertise in digital QC systems, and proven strategic capabilities in implementing and validating digital systems to achieve lean and compliant analytics. Experience with QC-LIMS systems, especially LabWare, and computer system validation are essential prerequisites for success in this high-impact strategic position.
Required Skills
Education
Not specified
Experience
- 7+ years in the GMP pharmaceutical or biopharmaceutical industry
- Proven track record of success as a leader
- In-depth experience with digital systems within Quality Control
- Extensive experience with QC-LIMS systems (e.g., LabWare)
- Experience with computer system validation
- Experience in strategy development and implementation of digital systems for QC
Languages
Additional
- Capability to represent Quality Control interests at the senior management level; Strong capability in challenging and reviewing QC-relevant processes across a network of sites.
More Jobs from BioNTech SE
Automation Engineer | Elektroingenieur (m/w/d)
Dec 16, 2025
This role focuses on providing deep technical automation support for critical process control system...
SHE Manager DACH | Biologe (m/w/d)
Dec 14, 2025
This role involves managing Safety, Health, and Environmental (SHE) compliance across multiple sites...
Senior Project Manager, QC Support | Biologe (m/w/d)
Dec 12, 2025
This Senior Project Manager role at BioNTech IMFS in Idar-Oberstein is pivotal for the manufacturing...