VP GMP Quality

Job Title: VP, Quality (GMPQA & GLP)Key Responsibilities:Lead the strategy and development of GMP/GLP 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 GMP/GLP 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 systems.In-depth knowledge of FDA regulations, cGMP, ICH guidance, and global health authority requirements for drug development and commercialization.

Created: 2025-01-27