Global Senior C&Q Program Lead for GMP Capital Projects

100 Eli Lilly and Company; Houston (TX); 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 major capital program. You will set CQV strategy, drive field execution, and ensure GMP compliance and ready-for-operations handover.

Leads a team of CQV firms, coordinates with construction, automation, and operations, and ensures on-time delivery of validated systems. Strong experience in API/biologics environments is a plus.

Qualifications

• Bachelors in Engineering, Life Sciences, or related field required.
• 15+ years CQV experience in GMP environments, including capital projects.
• Experience directing CQV contractors in complex construction environments.
• Experience delivering CQV in GMP pharma/life-sciences facilities.
• Familiarity with validation/commissioning platforms and related tools.

Responsibilities

• Create and own C&Q strategy, plans and schedules aligned to CQV standards.
• Lead field execution, review MC turnover, and close out punch items.
• Plan FAT with vendors, engineering, and construction teams.
• Author and approve CQ protocols, test scripts, and turnover data packages.
• Ensure regulatory compliance and audit readiness across the program.

Skills

CQV leadership

Contract management

Stakeholder influence

Large-scale projects

Regulatory compliance

Education

Bachelor's in Engineering

Master's degree

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 major capital program. You will set CQV strategy, drive field execution, and ensure GMP compliance and ready-for-operations handover.

Leads a team of CQV firms, coordinates with construction, automation, and operations, and ensures on-time delivery of validated systems. Strong experience in API/biologics environments is a plus.