Mainz, Germany | full time | Job ID: 11108
About the role:
At BioNTech, we are dedicated to driving innovation and excellence in the pharmaceutical industry. As Manager QA Compliance, you will play a pivotal role in ensuring compliance with global Marketing Authorization Holder (MAH) and Sponsor responsibilities. You will oversee the process landscape and global MAH/Sponsor Quality Management System (QMS) footprint, ensuring adherence to GMP and regulatory standards.
Your contribution:
1.
o You will act as Manager QA Compliance with a focus on GMP and regulatory processes to fulfill MAH/Sponsor responsibilities. This includes designing, maintaining, and optimizing the process landscape to ensure compliance and operational excellence.
o You will support discussions and decision-making processes with strategic partners on complex GMP and compliance matters. This involves coordinating and preparing comprehensive information, as well as organizing and supporting Quality forums and committees to drive alignment and collaboration.
o You will provide clear guidance to stakeholders, fostering a strong Quality mindset across the organization. Your role includes ensuring effective communication, advising and supporting peers, and networking to achieve company goals while maintaining compliance.
o You will contribute to the ongoing improvement of the pharmaceutical quality system in line with GMP Guide Chapter 1, ICH Guideline Q10, and regional/national guidelines.
o You will ensure regional compliance as a MAH/Sponsor representative, addressing evolving regulatory requirements.
o You will implement MAH/Sponsor Board processes, ensuring effective evaluation of quality metrics, trends, and compliance data to drive informed decision-making and continuous improvement initiatives.
o You will proactively maintain and report related metrics, identifying and mitigating risks to ensure compliance and operational efficiency.
o You will support inspections and audits related to MAH/Sponsor responsibilities, including preparation, coordination, and follow-up activities. Ensure readiness for regulatory inspections and provide expertise during inspection processes.
A good match:
*
o Degree in Pharmacy, Chemistry, Biology, or a related scientific field. Advanced degrees (e.g., MSc, PhD) are a plus.
o Extensive experience (5+ years) in Quality Assurance, GMP compliance, and regulatory processes within the pharmaceutical industry.
o Proven track record of managing MAH/Sponsor responsibilities and QMS frameworks.
o Strong knowledge of GMP guidelines, ICH Q10, and regional/national regulatory requirements.
o Exceptional communication and networking skills to foster collaboration across teams and stakeholders.
o Excellent written and verbal communication skills in English.
o 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).
Job ID 11108 (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.