Specialist QA Compliance
Mainz, Germany | full time | Job ID: 11106
About the role:
We are seeking a dedicated and skilled Quality Compliance Specialist to join our team and contribute to the development, implementation, and maintenance of a robust Marketing Authorization Holder (MAH) and Sponsor compliance process landscape. In this role, you will play a pivotal part in ensuring global compliance with regulatory requirements while fostering a culture of quality excellence across the organization. Your expertise will support strategic decision-making, drive collaboration, and strengthen our Quality Management System (QMS) footprint worldwide.
Your contribution:
In this role, you will:
- Support the design, implementation and maintenance of the MAH/Sponsor Processes landscape, ensuring compliance with global regulatory requirements.
- Facilitate discussions and decision-making processes with strategic partners on complex GMP and compliance matters, preparing comprehensive information and recommendations. Coordinate and support Quality forums and committees, driving collaboration and alignment across teams.
- Deliver training to stakeholders, fostering a clear understanding of compliance processes and promoting a quality-driven mindset throughout the organization.
- Act as a trusted advisor, supporting peers and stakeholders in achieving company goals while building strong networks within the Quality matrix organization. Provide support to other teams and areas with a cooperative and solution-oriented approach, ensuring seamless collaboration and problem resolution.
- Support the ongoing improvement of the pharmaceutical quality system in line with GMP Guide Chapter 1, ICH Guideline Q10, and regional/national guidelines.
- Maintain and report related metrics, proactively identifying risks and implementing mitigation strategies to ensure compliance and operational excellence.
A good match:
- A degree in Life Sciences, Pharmacy, Chemistry, or a related field. Advanced degrees or certifications in Quality Management or Regulatory Affairs are a plus.
- Proven experience (3+ years) in GMP Compliance, Quality Management Systems, and MAH/Sponsor processes within the pharmaceutical or biotech industry.
- Strong analytical and problem-solving skills with the ability to interpret complex regulatory requirements and translate them into actionable processes.
- Demonstrated ability to work collaboratively in a matrix organization, building relationships and networks across teams and stakeholders.
- A proactive approach to identifying risks and driving continuous improvement initiatives.
- Excellent written and verbal communication skills in English, with the ability to deliver training and present information effectively to diverse audiences.
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 11106 (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.