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