Manager Global QA Compliance (Mainz, RP, DE, 55131)

Biopharma Careers; 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

Company bike

Job ticket

Deutschlandticket

Employer-funded pension

Childcare

Zusammenfassung

BioNTech is seeking a Manager Global QA Compliance to ensure GxP QA oversight across the MAH/Sponsor network, scientifically justify and risk‑assess Quality Events, and maintain compliance with global regulations.

You will guide stakeholders on Quality Event management, support inspection readiness and governance activities, and drive continuous improvement to strengthen quality oversight and regulatory performance.

Qualifikationen

• 5+ years in QA, GMP/GDP compliance and regulatory processes.
• Experience managing MAH/Sponsor responsibilities and QMS.
• Knowledge of Change Control and Deviations processes.
• Strong knowledge of GMP/GDP guidelines, ICH Q10, ICH Q9 and regulatory requirements.
• Excellent written and verbal English communication.
• Analytical mindset for complex compliance challenges.

Aufgaben

• Perform independent QA review for GxP-relevant Quality Events across the MAH/Sponsor network.
• Support governance activities and decision-making on Quality Events.
• Provide guidance on regulatory expectations and Quality Risk Management.
• Oversee Quality Events lifecycle and documentation.
• Collaborate with stakeholders to drive compliance and improvements.
• Support inspection and audit readiness activities.

Kenntnisse

Quality Assurance

GMP/GDP compliance

Regulatory processes

Change Control

QMS frameworks

Communication skills (English)

Ausbildung

Degree in Pharmacy, Chemistry, Biology, or related field

Advanced degrees (MSc, PhD) a plus

Jobbeschreibung

Mainz, Germany | full time

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

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.