Associate Director – Validation
Core
Leading and managing the validation program within Facilities and Engineering to ensure compliance with cGMP regulations for pharmaceutical facilities and equipment.
Role type
Senior IC validation program director
Builds
Validated facilities, equipment, and processes for pharmaceutical manufacturing
Domain
Pharmaceutical manufacturing / Regulatory compliance
Required skills
Validation program management, cGMP/FDA/EMA regulatory knowledge, project management, technical team leadership, gap assessment and remediation, audit support, process improvement
Preferred skills
Master's degree in Engineering or life sciences, experience with capital engineering projects, matrix approach practices
Technologies
Enterprise Quality Vault (EQV), CQV processes
Responsibilities
Establish site validation strategy aligned to cGMP, lead development and execution of validation strategies and documentation, manage complex validation projects including asset specification and procurement, conduct internal validation assessment audits, develop validation gap assessment and remediation plans
Seniority
Senior, hands-on IC