Senior C&Q Program Lead

BioSpace

Huntsville (AL)

On-site

USD 159,000 - 233,000

Full time

8 days ago

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Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Time off

Job summary

Lilly is seeking a Senior Program C&Q Lead to own commissioning and qualification strategies for capital programs, ensuring GMP-compliant delivery and readiness for startup and handover to Operations. This senior role requires technical ownership of CQV and strong collaboration with engineering, construction, and QA teams.

The position emphasizes leading CQV execution in the field, FAT oversight, and driving continuous improvement while coordinating with vendors and site teams.

Qualifications

Bachelor's in Engineering, Life Sciences, or related field.
15+ years of commissioning, qualification, and validation (CQV) in GMP environments.
Experience leading CQV on capital projects.
Able to travel globally, ~35% US/intl.
Authorized to work in the United States full-time.

Responsibilities

Own C&Q strategy, plans, and schedules per program.
Direct day-to-day C&Q execution in the field.
Lead FAT planning and execution with vendors.
Coordinate handover to Site Operations and training.
Ensure compliance with regulatory and quality standards.
Drive continuous improvement of CQV methods.

Skills

CQV leadership

GMP validation

Project management

Cross-functional collaboration

Travel willingness

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Kneat

Oracle Unifier

Smartsheet

Power BI

Job description

The position emphasizes leading CQV execution in the field, FAT oversight, and driving continuous improvement while coordinating with vendors and site teams.

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