Senior CQV Program Lead — GMP Validation and Start-up

100 Eli Lilly and Company; Richmond (VA); On-site; USD 164,000 - 240,000; Full time

Job summary

Lilly is seeking a Senior Program C&Q Lead to own commissioning and qualification for a capital program, setting the CQV strategy, driving field execution, and ensuring GMP-compliant systems ready for startup and handover to Site Operations.

You will lead C&Q in a complex, matrixed environment, coordinate FAT with vendors, and ensure audit-ready records while advancing continuous improvement across CQV standards.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 15+ years of CQV experience in GMP-regulated environments.
• Hands-on validation lifecycle experience across commissioning, qualification, startup and handover.
• Experience planning and executing FAT with equipment vendors.
• Ability to travel up to 35% and work in the United States.
• Authorized to work in the United States full-time; sponsorship not provided.
• Preferred: directing CQV contractors and mega-capital projects.
• Familiarity with Kneat, Oracle Unifier, Smartsheet and Power BI.

Responsibilities

• Create, own, and implement the C&Q strategy, plans, and schedules for the assigned program.
• Direct day-to-day C&Q execution in the field through contractors and CQV resources.
• Coordinate FAT, acceptance testing, and vendor interactions for equipment and systems.
• Ensure audit-ready records, documentation turnover, and smooth handover to Operations.
• Report progress, risks, and issues to program leadership with clear metrics.

Skills

CQV

Validation lifecycle

FAT planning

Project coordination

Education

Bachelor's in Engineering, Life Sciences, or related field

Master's degree in engineering/science

Tools

Kneat

Oracle Unifier

Smartsheet

Power BI

Job description

Lilly is seeking a Senior Program C&Q Lead to own commissioning and qualification for a capital program, setting the CQV strategy, driving field execution, and ensuring GMP-compliant systems ready for startup and handover to Site Operations.

You will lead C&Q in a complex, matrixed environment, coordinate FAT with vendors, and ensure audit-ready records while advancing continuous improvement across CQV standards.