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
Director/Senior Director, GMP Quality in boston at Unknown Company
This position is listed as full time and onsite.