Meet Life Sciences
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.