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Associate Director Global Supplier Qualification
BioNTech
Source: Headcount Labs · original listing ↗
Job data: Headcount Labs, ODbL 1.0. Job descriptions belong to their employers.
Posted Oct 22
About this role
Mainz, Germany | full time | Job ID: 11849 About the role: As Associate Director Global Supplier Qualification you help ensure that suppliers and contract manufacturers meet the quality standards needed for late-stage clinical studies and commercial supply. Your work supports the reliable delivery of products that contribute to BioNTech’s mission. You partner with teams across Quality, Supply Chain and Manufacturing, as well as external suppliers. From qualification and audits to change assessments and governance, you help keep supplier oversight clear, consistent and effective. Your contribution: • Lead qualification and oversight of suppliers and contract manufacturers for late-stage clinical studies and commercial products, in line with Good Manufacturing Practice and Good Distribution Practice requirements • Plan and lead supplier audits, document findings and coordinate follow-up actions with suppliers and internal experts • Support project teams with supplier qualification for Phase 2 and Phase 3 clinical studies • Assess supplier notifications, including changes, deviations and risk assessments, and coordinate claims with suppliers and subject matter experts • Maintain supplier records in Veeva and represent Supplier Quality in governance meetings, contract manufacturer reviews and cross-functional forums • Coordinate supplier quality topics across local and global Quality, Qualified Persons, Supply Chain, Clinical Trial Supply Management and Manufacturing Science and Technology A good match: • A degree in life sciences, such as chemistry, biology, pharmacy, or an equivalent field. • At least 8+ years of professional experience in a similar role within a GMP/GDP environment. • Qualification as a GMP and GDP lead auditor, with demonstrated experience leading supplier audits • Strong expertise in Veeva eQMS and supplier qualification processes. • Strong Experience managing contract manufacturers and other outsourced GMP service providers, including across manufacturing, quality control or supply chain. • Experience supporting products through late-stage development, registration, commercialization and commercial supply • Fluent German and English, both written and spoken. • Strong coordination and communication skills to align internal stakeholders and external partners on supplier quality topics Your Benefits: It's our priority to support you: • Your flexibility: flexible hours | vacation account • Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning • Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential • Your health and lifestyle: Company bike • Your mobility: Job ticket | Deutschlandticket • Your life phases: Employer-funded pension | Childcare Apply now - We look forward to your application! Apply to our Mainz, Germany location 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 11849 (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. Note for applications within Europe: Please note that if you wish to claim travel expenses incurred in connection with an in-person interview, we are obliged to carry out a sanctions list check*. This is carried out by our partner, HireRight. Travel expenses will only be reimbursed if this sanctions list check does not yield any matches. Reimbursement can be made provided that the check is successfully completed. * Your first name, surname and date of birth will be processed for the sanctions list check. The legal basis for carrying out the sanctions list check for positions at BioNTech in Europe is BioNTech’s legitimate interest. Please note that BioNTech will not carry out the sanctions list check if no travel expenses are to be reimbursed. If you do not give BioNTech your consent to the sanctions list check, your travel expenses cannot be reimbursed. This will not affect your application.