Manager GQA Compliance

Manager GQA Compliance

At BioNTech, we are dedicated to driving innovation and excellence in the pharmaceutical industry. As Manager GQA 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.

About the role:

Your contribution:

• You will act as Manager GQA 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).

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.