Senior Director, GMP Quality Assurance

Description: Seeking a Senior Director, GMP Quality Assurance to oversee quality for oncology and rare disease drug discovery projects. Responsible for quality oversight of externally manufactured drug substances and solid oral dose products, including batch disposition and inspection readiness. Requirements: Bachelor’s Degree in Chemistry, Biochemistry, Pharmacy, Chemical Engineering, or related field with 15+ years of GMP Quality Assurance experience, including 8+ years in leadership. Extensive experience with outsourced small molecule manufacturing and supporting NDA submissions. Knowledge of regulatory requirements (21 CFR, EU GMP, ICH) and experience with electronic Quality Management Systems. Benefits: Competitive salary range of $290,469 - $317,518 USD, with bonuses and equity packages. Employer-paid medical, dental, vision insurance, life insurance, and disability coverage. 401(k) plan with company match, flexible vacation, paid parental leave, and tuition assistance.