Senior C&Q Program Lead for GMP Validation

BioSpace; Houston (TX); On-site; USD 164,000 - 240,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Leave benefits

Well-being benefits

Job summary

The Senior Program C&Q Lead at Lilly owns commissioning and qualification for an assigned capital program or site, setting the C&Q strategy, driving field execution, and delivering systems that are validated, GMP-compliant, and ready for reliable startup and handover to Site Operations.

This is a senior individual contributor role: the Senior Program C&Q Lead is Lilly's technical owner and single point of accountability for C&Q on the program.

Qualifications

• Bachelor's degree in engineering, life sciences, or a related field.
• 15+ years CQV/ commissioning and validation in GMP environments.
• Experience leading CQV on capital projects; FAT delivery and handover.
• Willingness to travel within the US; authorized to work in the US.

Responsibilities

• Own the CQV strategy, plans, and schedules for the program with integration to platforms.
• Direct day-to-day CQV execution in field and coordinate with teams.
• Plan FATs, review protocols, and ensure audit-ready records.
• Lead handover to Operations with training support and documentation turnover.
• Ensure safety, quality, and regulatory compliance throughout CQV activities.

Skills

CQV leadership

GMP experience

Project management

Regulatory compliance

FAT execution

Field coordination

Travel readiness

Stakeholder management

Education

Bachelor's in Engineering or Life Sciences

Master's degree (preferred)

Tools

Kneat

Oracle Unifier

Smartsheet

Power BI

Job description

The Senior Program C&Q Lead at Lilly owns commissioning and qualification for an assigned capital program or site, setting the C&Q strategy, driving field execution, and delivering systems that are validated, GMP-compliant, and ready for reliable startup and handover to Site Operations.

This is a senior individual contributor role: the Senior Program C&Q Lead is Lilly's technical owner and single point of accountability for C&Q on the program.