VP GMP Quality

Job Title: VP, Quality (GMPQA & GLP)Key Responsibilities:Lead the strategy and development of GMPGLP quality functions, ensuring compliance with global regulatory requirements for manufacturing, preclinical, and testing operations.Manage and mentor a high-performing team, providing support, guidance, and professional development.Serve as the technical subject matter expert for GMPGLP regulations, overseeing implementation of quality systems and processes in manufacturing, testing, and analytics.Collaborate with cross-functional teams to integrate quality processes, support CMC and IND document review, and ensure continuous improvement in quality standards across product development.Qualifications:Bachelor's or advanced degree in Biology, Chemistry, Chemical Engineering, or related field.15+ years of GMP Quality Assurance experience, with a strong background in small molecule manufacturing and solid oral dosage forms.Proven leadership experience (10+ years) in managing teams, fostering collaboration, and driving performance excellence in quality -depth knowledge of FDA regulations, cGMP, ICH guidance, and global health authority requirements for drug development and commercialization.

Created: 2025-01-28