Senior CQV Program Lead for GMP Facilities

Initial Therapeutics, Inc.; Huntsville (AL); On-site; USD 159,000 - 233,000; Full time

Job summary

Lilly seeks a seasoned CQV leader to manage commissioning, qualification, and validation across capital projects in GMP environments. Define strategy, plan schedules, lead FATs, and oversee handover to operations, ensuring compliance and audit readiness.

Travel within the US up to 35% is required; strong CQV lifecycle, regulatory, and vendor coordination expertise are essential for on-time project delivery. This role emphasizes influencing without direct authority and driving CQV improvements.

Qualifications

• Bachelor's in Engineering, Life Sciences, or related field.
• 15+ years of commissioning, qualification, and validation (CQV) experience in GMP environments; leading CQV on capital projects.
• Hands-on experience across the validation lifecycle – commissioning, qualification, systems turnover, startup support, handover to operations.
• Experience planning and executing FAT with equipment vendors.
• Willingness to travel within and outside the US, ~35%.
• Authorized to work in the United States on a full-time basis.

Responsibilities

• Define C&Q strategy, plans, and schedules for the assigned program, aligned to CQV standards.
• Direct day-to-day C&Q execution in the field and ensure adherence to procedures.
• Review and accept MC turnover and drive punch list closeout with CQV firms.
• Coordinate FAT and pre-commissioning activities.
• Lead handover to User teams and Site Operations with proper documentation.

Skills

CQV leadership

GMP compliance

Project management

Regulatory knowledge

Travel readiness

Education

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

Master's degree in engineering/science (preferred)

Tools

Kneat

Oracle Unifier

Smartsheet

Power BI

Job description

Lilly seeks a seasoned CQV leader to manage commissioning, qualification, and validation across capital projects in GMP environments. Define strategy, plan schedules, lead FATs, and oversee handover to operations, ensuring compliance and audit readiness.

Travel within the US up to 35% is required; strong CQV lifecycle, regulatory, and vendor coordination expertise are essential for on-time project delivery. This role emphasizes influencing without direct authority and driving CQV improvements.