Manager Global QA Compliance

Job description

Mainz, Germany | full time | Job ID: 11716 About the role: At BioNTech, we are dedicated to driving innovation and excellence in the pharmaceutical industry. As Manager Global QA Compliance, you will play a pivotal role in ensuring compliance with global Marketing Authorization Holder (MAH) and Sponsor responsibilities. You will ensure that GxP-relevant Quality Events are scientifically justified, appropriately risk-assessed, and compliant with applicable global regulations. You will provide Quality Assurance oversight for GxP-relevant Quality events across the MAH/Sponsor network and contribute to inspection readiness, governance activities, and continuous improvement initiatives. Your contribution: You will act as Manager QA Compliance, performing independent Quality Assurance review for GxP-relevant Quality Events across the MAH/Sponsor network, ensuring appropriate assessment, effective resolution, and compliance with applicable global regulations and company requirements. You will support cross-functional decision-making and governance activities related to Quality Events, ensuring appropriate quality, compliance, and risk management considerations are addressed. You will provide guidance and expertise to stakeholders on Quality Event management, regulatory expectations, and Quality Risk Management principles, fostering a strong quality culture across the organization. You will review and oversee Quality Events throughout their lifecycle, ensuring timely assessment, appropriate investigations, implementation of actions, and compliant documentation. You will collaborate with internal and external stakeholders to support effective Quality Event management and drive continuous compliance and operational excellence. You will monitor quality and compliance trends, identify risks, and support continuous improvement initiatives to strengthen quality oversight and compliance performance. You will support inspection and audit readiness activities, providing Quality Event expertise during internal audits, partner audits, and regulatory inspections. A good match: Degree in Pharmacy, Chemistry, Biology, or a related scientific field. Advanced degrees (e.g., MSc, PhD) are a plus. Extensive experience (5+ years) in Quality Assurance, GMP/GDP compliance, and regulatory processes within the pharmaceutical industry. Proven track record of managing MAH/Sponsor responsibilities and QMS frameworks. Experience with Change Control, Deviations, etc. processes within a pharmaceutical or biotechnology environment and understanding of product lifecycle management. Strong knowledge of GMP/GDP guidelines, ICH Q10, ICH Q9 and regional/national regulatory requirements. Exceptional communication and networking skills to foster collaboration across teams and stakeholders. Excellent written and verbal communication skills in English. Analytical mindset with the ability to navigate complex compliance challenges and drive solutions. 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 11716 (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.