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Director, CMC QA
Korro BioRNA editing company
Cambridge, United StatesDirector
Venrock Healthcare Capital Partners
ADAR1 Capital Management
Affinity Asset Advisors
Balyasny Asset Management
Driehaus Capital Management
Kalehua Capital
Operations & Strategy
About the role
TL;DR
The Director, CMC QA will oversee quality systems, vendor oversight, and regulatory compliance for Korro Bio's clinical development programs.
- •Key Responsibilities Ensure compliance with regulatory requirements and internal quality standards.
- •Lead clinical lot disposition and batch record review.
- •Oversee GMP Quality Systems activities at external partners.
- •Plan and conduct cGMP audits of external partners.
- •Provide quality and technical input to cross-functional project teams.
- •Requirements Bachelor's degree in Chemistry, Biology, or Life Sciences.
- •Minimum of 10 years of cGMP-related experience.
- •Demonstrated knowledge of Quality Systems and cGMP within an FDA-regulated environment.
- •Auditing experience is required.
Required skills
Compliance Management
Nice-to-have skills
Negotiation
Domain expertise
biotech