Verification Program Lead

Responsibilities

• Own and lead the end-to-end Commissioning & Qualification (C&Q) strategy for a large-scale peptide/API capital project.
• Define system boundaries, risk-based verification approach, and overall CQV execution model.
• Build, scale, and lead a multi-discipline CQV team (20+ at peak).
• Serve as primary verification interface to Engineering, QA, MSAT, Operations, EPCs, and OEMs.
• Ensure alignment between design, construction, and qualification activities.
• Establish governance structure, KPIs, reporting cadence, and delivery milestones.
• Oversee verification of process equipment, clean utilities, facilities, and automation systems.
• Drive compliance with FDA and global regulatory expectations.

Qualifications

• 15+ years of experience in pharmaceutical or biotech manufacturing.
• 7+ years leading large-scale CQV or validation programs.
• Experience supporting major capital projects ($250M+ preferred).
• Strong background in API, peptide, biologics, or sterile manufacturing environments.
• Proven ability to build and lead high-performing technical teams.
• Deep understanding of lifecycle validation, risk-based qualification, and regulatory compliance.
• Excellent cross-functional leadership and executive communication skills.