Senior CQV Program Lead – GMP Capital Projects

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

Benefits offered by this job

401(k) Plan

Pension

Health benefits

Job summary

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

You will manage CQV planning, execution, FAT, and documentation, collaborating with construction, automation, QA, and operations while maintaining regulatory compliance and a strong safety culture. Global capital projects experience preferred.

Qualifications

• Bachelor's in Engineering, Life Sciences, or a related field.
• 15+ years of commissioning, qualification, and validation (CQV) experience in GMP-regulated environments, including leading C&Q execution on capital projects.
• Hands-on experience across the validation lifecycle – commissioning, qualification, systems turnover, startup support, and handover to operations.
• Ability to travel, both within and outside the US as required, ~35% expected.
• Authorized to work in the United States on a full-time basis; Lilly will not sponsor work authorization.

Responsibilities

• Create, own, and implement the C&Q strategy, plans, and schedules for the assigned program, aligned to CQV standards and network requirements.
• Direct day-to-day C&Q execution in the field through firms and contingent leads; ensure adherence to procedures and strategy.
• Plan and lead FAT for the program with vendors, engineering, and construction.
• Lead or support system handover to Operations, including training support and documentation turnover.
• Manage C&Q change and deviation processes, ensuring compliant records and audit readiness.

Skills

CQV leadership

Project management

Regulatory compliance

Strategic planning

Education

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

Master's degree preferred

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 CQV strategy and driving field execution to deliver validated, GMP-compliant systems ready for startup and handover to Site Operations.

You will manage CQV planning, execution, FAT, and documentation, collaborating with construction, automation, QA, and operations while maintaining regulatory compliance and a strong safety culture. Global capital projects experience preferred.