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VP GMP Quality

Meet
San Francisco, CA Full Time
POSTED ON 2/7/2025
AVAILABLE BEFORE 4/29/2025

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.
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