Executive Director, QA Microbiology
RegeneronTempe, Arizona, United States
Posted March 25, 2026
239600 - 399400 USD
Full Time
About the Company
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in. Please visit www.regeneron.com/social-media-terms for information on how to engage with us on social media. An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media.
Job Description
The Executive Director, QA Microbiology is responsible for the development and execution of the strategy and plan for the Regeneron GMP Microbiology program, providing direction to functional areas to ensure high-quality, safe, and effective products compliant with global regulatory expectations.
Requirements
- Comprehensive knowledge of microbiological expectations throughout the drug development process, pharmaceutical technology, drug manufacturing processes, and related issues, drug laws, global regulations, and guidelines, particularly CMC and GMP.
- Experience building up a quality culture and quality management capabilities.
- Comprehensive knowledge and experience in CMC section content for investigational and marketed product submissions (IND, BLA, CBE, PAS) for FDA and equivalent submissions for Europe.
- Ability to articulate and execute concepts for developing and ensuring the highest quality throughout the network (internal and external).
- Intellect for quality risk identification, mitigation, and management.
- Strong communication skills —written and oral.
- Experience with businesses in different phases of the business lifecycle and the quality and validation issues associated with these phases.
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)
