Senior CQV Program Lead for GMP Asset Startups

Biopharma Careers; Huntsville (AL); On-site; USD 159,000 - 233,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Job summary

Lilly seeks a Senior Program C&Q Lead to own commissioning and qualification across a global capital program, aligning CQV strategy with platform and network requirements. You will drive field execution, ensure systems are validated and ready for startup, and handover to Site Operations.

Ideal candidates have 15+ years in CQV within GMP environments, with FAT planning experience and strong leadership, vendor coordination, and regulatory knowledge. Travel up to 35% is expected.

Qualifications

• Bachelor's in Engineering, Life Sciences, or related field required.
• 15+ years CQV experience in GMP environments with capital projects.
• Hands-on validation lifecycle experience from commissioning to handover.
• Ability to travel up to ~35% and support field deployment.

Responsibilities

• Own C&Q strategy for assigned capital program and coordinate field execution.
• Plan FAT, review protocols, establish schedules, and ensure audit-ready records.
• Lead handover to operations, maintain GMP compliance, and drive continuous improvement.

Skills

CQV expertise

Project management

Regulatory compliance

Leadership

Communication

Education

Bachelor's in Engineering

Tools

Kneat

Oracle Unifier

Smartsheet

Power BI

Job description

Lilly seeks a Senior Program C&Q Lead to own commissioning and qualification across a global capital program, aligning CQV strategy with platform and network requirements. You will drive field execution, ensure systems are validated and ready for startup, and handover to Site Operations.

Ideal candidates have 15+ years in CQV within GMP environments, with FAT planning experience and strong leadership, vendor coordination, and regulatory knowledge. Travel up to 35% is expected.