Validation Program Lead

Job Responsibilities:

• Own verification strategy from basic design through execution
• Define system boundaries, risk-based approach, and integrated C&Q model
• Lead and scale a multi-discipline CQV organization (20+ at peak)
• Act as senior interface to GFD, EPCs, OEMs, QA, MSAT, and Operations
• Drive schedule-critical decisions with minimal supervision
• Ensure inspection-ready delivery aligned to GMP, ASTM E2500, ISPE
• Establish governance, reporting, escalation, and execution cadence

Qualifications:

• 10+ years progressive experience across C&Q, validation, and capital projects
• Proven leadership of large-scale GMP capital programs ($200M–$1B)
• Demonstrated ownership of design-phase verification strategy
• API / peptide / complex purification manufacturing strongly preferred
• Experience leading commissioning-forward, risk-based C&Q models
• Prior Lilly experience highly valued but not required