Senior C&Q Program Lead - GMP/Utilities (Pharma)

Quanta Consultancy Services Ltd; Kentucky; On-site; USD 180,000 - 320,000; Full time

Job summary

Quanta Consultancy Services Ltd is seeking a C&Q Program Lead to support a mega pharmaceutical build in Ohio, guiding commissioning and qualification across the project.

You will own strategy, coordinate CQV teams, manage contractors, and drive schedule and risk mitigation while ensuring GMP, GEP, and ASTM standards are met.

This role requires senior leadership and a track record on large capital facilities in regulated pharma, with strong cross-functional collaboration.

Qualifications

• Bachelor's degree in Engineering (Chemical/Mechanical) or related.
• Extensive experience in commissioning & qualification / startup within pharmaceutical, API, or regulated manufacturing.
• Experience in a lead capacity managing major capital construction projects valued between $500 million and $2 billion.
• Demonstrated experience leading C&Q programs on capital projects and managing execution contractors.
• Knowledge of utilities and/or solvent / tank farm systems strongly preferred.
• Risk-based C&Q (ASTM E2500 / GEP) and GMP requirements for utilities and bulk chemical systems.
• Clean utilities (WFI, clean steam, PW), HVAC, black utilities, and/or bulk solvent storage, distribution, and recovery.

Responsibilities

• Lead the overall C&Q programme strategy and execution, ensuring alignment with quality, safety, and project objectives.
• Act as the primary C&Q representative, coordinating multiple CQV teams from planning and documentation through to qualification and project handover.
• Oversee C&Q contractors, managing scope, deliverables, performance, and successful programme delivery.
• Own key C&Q milestones, schedules, and risks, driving mitigation plans to maintain project timelines.
• Lead cross-functional collaboration between Engineering, Construction Management, CQV teams, Project Leadership, and Site Operations stakeholders.
• Ensure all commissioning and qualification activities comply with GMP, GEP, ASTM E2500, and site quality standards while maintaining inspection readiness.
• Manage mechanical completion and construction turnover activities, ensuring systems are handed over efficiently with complete and compliant documentation.

Skills

CQV leadership

Program management

Regulated pharma

Risk-based GMP

Stakeholder coordination

Vendor/contractor management

Education

Bachelor's degree in Engineering

Job description

Quanta Consultancy Services Ltd is seeking a C&Q Program Lead to support a mega pharmaceutical build in Ohio, guiding commissioning and qualification across the project.

You will own strategy, coordinate CQV teams, manage contractors, and drive schedule and risk mitigation while ensuring GMP, GEP, and ASTM standards are met.

This role requires senior leadership and a track record on large capital facilities in regulated pharma, with strong cross-functional collaboration.