Quality Director
Scorpion Therapeutics
Role Associate Director, GMP Quality Assurance, leading quality oversight for biologics manufacturing, testing, and packaging to ensure compliance with global GMP regulations. Responsibilities review and approve GMP documents support investigations of deviations and OOS/OOT results conduct internal audits qualify external suppliers and CDMOs maintain quality agreements prepare for regulatory inspections Focuses on integrating AI technologies to enhance QA processes. Requirements Bachelor's in Chemistry, Biology, Engineering, or Pharmaceutical Sciences 10+ years in GMP QA within biologics/large-molecule manufacturing deep knowledge of FDA, EMA, ICH standards strong communication, documentation, and leadership skills experience with CMO oversight or virtual manufacturing models High Value Keywords biologics large-molecule GMP manufacturing quality investigations supplier qualification regulatory compliance AI integration Work Setup hybrid NYC/Boston; willingness to relocate or commute. Travel not specified #J-18808-Ljbffr
Vacancy posted 3 days ago
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