Associate Director CMC Excellence & Compliance
Mainz, Germany | full time | Job ID: 9832
The Associate Director CMC Excellence & Compliance ensures that the employees and systems within Global Technical Development (GTD) maintain robust compliance with internal policies and evolving GxP requirements.
By leading GTD-wide training compliance, safeguarding data integrity and digital compliance, and developing frameworks, documentation and processes for audit and submission readiness, this role strengthens GTD's ability to embed compliance into business processes, quality systems, and digital platforms. The Associate Director will coordinate with GTD Leadership, CMC RA, Quality, and IT to ensure compliance expectations are clearly defined, consistently implemented, and monitored across functions, while driving continuous improvement initiatives to maintain inspection readiness and GxP alignment.
This is a role for an experienced professional with strong expertise in compliance frameworks, process improvement methodologies and emerging digital technologies. The successful candidate will have the opportunity to impact critical cross-functional projects and contribute to the growth and success of a leading biotech company.
Your main responsibilities are:
- Ensure GTD-wide training alignment, maintain training profiles, and secure audit and inspection readiness
- Develop, implement, and oversee compliance frameworks, processes, and documentation within GTD to support GxP requirements
- Safeguard data integrity and ensure digital compliance by aligning processes, data and systems within GTD to global digitalization initiatives
- Ensure adherence to quality systems, serve as key user for platforms (e.g., Veeva eQMS ), and maintain ownership of guidance documents relevant to CMC development (e.g., QbD)
- Collaborate with Quality, Regulatory, and IT to maintain compliance across systems, monitor performance, identify gaps, and drive continuous improvement initiatives
What you have to offer:
- Master’s degree in pharmacy, Chemistry, Life Sciences, or related field with 5+ years in pharmaceutical development, process improvement, or compliance
- Deep understanding of global GxP requirements and regulatory frameworks (FDA, EMA, ICH)
- Experience in designing and delivering compliance training programs
- Proficient in digital compliance tools, data integrity, and emerging pharma technologies
- Expertise in CMC documentation standards, audit readiness, and submission processes
- Strong leadership and stakeholder management skills to coordinate across internal and external matrix teams and embed compliance into business processes
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 12 PM to 4 PM CET).
Job ID 9832 (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.