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 Requirements 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 #J-18808-Ljbffr Jobtailor