Director​/Senior Director, GMP Quality

Responsibilities

• Support the Head of QA with oversight of Verastem Quality Systems and QA activities in accordance with GXP requirements
• Develop and implement procedures, policies, and systems to support commercial and clinical stage operations
• Drive compliance with current regulations and oversight of external GMP Quality operations at partner and CMO sites
• Help define and drive the Quality vision and mindset
• Define clear Quality objectives and ensure cross-functional completion of responsibilities
• Collaborate with Quality organization, Technical Operations, Supply Chain and CMO Sites
• Review batch records and analytical data for conformance to specifications and regulations
• Review and approve external product technical investigations and deviations
• Actively support validation and implementation of new electronic Quality Systems

• Bachelor’s degree in a scientific field; advanced degree preferred
• Minimum of 15+ years of Quality Assurance/Manufacturing Operations experience in pharmaceutical or biotech industry
• In-depth knowledge of GMP and QA principles, practices and standards
• Through understanding of FDA, EMA and ICH quality regulations
• Excellent verbal and written communication skills to effectively communicate with colleagues and vendors
• Strong team player with a customer service approach and solution-oriented attitude
• Works effectively and autonomously in a lean/flexible organization
• Experience with Regulatory/Health Authority Inspections