Senior QA Director, Compliance & Quality Systems
Listed on 2026-07-20
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Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers, Quality Engineering
• 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
🔍 ATS Optimization Keywords
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Hard Skills
- Quality Systems Development
- GMP Compliance
- Quality Objectives Definition
- Batch Record Review
- Analytical Data Review
- Technical Investigation Approval
- Validation of Electronic Quality Systems
Soft Skills
- Excellent Communication Skills
- Team Player
- Customer Service Approach
- Solution-Oriented Attitude
- Autonomous Work Style
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