Manager GQA Compliance

About the Position

We are looking for a Manager GQA Compliance to join our team in Mainz, Germany. In this role, you will ensure compliance with global Marketing Authorization Holder (MAH) and Sponsor responsibilities, providing Quality Assurance oversight for GxP-relevant Quality events across the MAH/Sponsor network.

Responsibilities

• 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.
• Support cross-functional decision-making and governance activities related to Quality Events, ensuring appropriate quality, compliance, and risk management considerations are addressed.
• 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.
• Review and oversee Quality Events throughout their lifecycle, ensuring timely assessment, appropriate investigations, implementation of actions, and compliant documentation.
• Collaborate with internal and external stakeholders to support effective Quality Event management and drive continuous compliance and operational excellence.
• Monitor quality and compliance trends, identify risks, and support continuous improvement initiatives to strengthen quality oversight and compliance performance.
• Support inspection and audit readiness activities, providing Quality Event expertise during internal audits, partner audits, and regulatory inspections.

Requirements

• 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.

We Offer

• Flexibility: Flexible hours | Vacation account
• Growth: Digital Learning | Performance & talent development | Leadership development | Apprenticeships | LinkedIn Learning
• Value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
• Health and Lifestyle: Company bike
• Mobility: Job ticket | Deutschlandticket
• Life Phases: Employer-funded pension | Childcare

About the Company

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

BioNTech - As unique as you

www.biontech.com

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 11851 (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.

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