Associate Director CMC Excellence & Compliance

Associate Director CMC Excellence & Compliance

Join to apply for the Associate Director CMC Excellence & Compliance role at BioNTech SE

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.

Your main responsibilities

• 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

• Flexible hours | vacation account
• Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
• Your 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

Apply now - We look forward to your application

Apply to our Mainz, Germany location by sending your documents via our online form. For any questions, contact our talent acquisition team at +49 (0) (Monday-Friday from 12 PM to 4 PM CET).

Job ID: 9832.

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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