Manager Global QA Compliance

Gudejobs; Mainz; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Flexible hours

Vacation account

Digital Learning

Performance & talent development

Leadership development

Apprenticeships

LinkedIn Learning

Voice at the table

Culture on an equal footing

Opportunities to shape & impact

Support for your full potential

Company bike

Job ticket

Deutschlandticket

Employer-funded pension

Childcare

Zusammenfassung

BioNTech is seeking a Manager Global QA Compliance in Mainz to ensure MAH/Sponsor responsibilities meet global GxP standards. You will oversee QA reviews of GxP events, guide risk management, and support regulatory readiness across the MAH network.

The role requires 5+ years in QA, GMP/GDP compliance, and strong knowledge of ICH guidelines, with excellent English communication. This on-site position offers impactful work in a leading biotech environment and opportunities for global collaboration.

Qualifikationen

• Degree in Pharmacy, Chemistry, Biology or related scientific field.
• 5+ years of experience in Quality Assurance, GMP/GDP compliance, and regulatory processes within pharma.
• Proven track record managing MAH/Sponsor responsibilities and QMS frameworks.
• Experience with Change Control and Deviations processes in pharma/biotech.
• Strong knowledge of GMP/GDP guidelines, ICH Q10, ICH Q9 and regulatory requirements.
• Excellent written and verbal English communication.

Aufgaben

• Act as Manager QA Compliance, performing independent QA review for GxP-related Quality Events across the MAH/Sponsor network.
• Support cross-functional decision-making and governance related to Quality Events.
• Provide guidance on Quality Event management, regulatory expectations, and Quality Risk Management.
• Review and oversee Quality Events lifecycle: assessment, investigations, actions, documentation.
• Collaborate with internal and external stakeholders to support Quality Event management.
• Monitor trends, identify risks, and drive continuous improvement in quality oversight.
• Support inspection and audit readiness activities with QA event expertise.

Kenntnisse

Quality Assurance

GMP GDP compliance

Regulatory processes

Change Control

Deviations

English communication

Ausbildung

Degree in Pharmacy, Chemistry, Biology

MSc/PhD a plus

Jobbeschreibung

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:

• 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

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.

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BioNTech, the story

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, encouragecreativity, 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