About this role
BioNTech
Mainz, Germany | full time | Job ID: 11851
About the role
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.
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
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