Senior C&Q Lead

QCS Staffing Ltd; Ohio; On-site; USD 130,000 - 170,000; Full time

Job summary

QCS Staffing Ltd in the United States (Ohio) seeks a Senior C&Q Lead to drive commissioning and qualification for a major Life Sciences project. You will shape the C&Q strategy, coordinate with engineering, construction, QA, and vendors, and ensure compliance with GMP and safety requirements.

The role requires extensive GMP experience, mastery of the full C&Q lifecycle, and proven leadership of cross-functional teams on large capital projects.

Qualifications

• Extensive experience in Commissioning & Qualification within GMP regulated industries (pharmaceutical/biotech).
• Mastery of the full C&Q lifecycle (DQ, FAT, SAT, IQ/IV, OQ/OV, PQ/PPQ).
• Proven leadership of multidisciplinary teams on large capital projects.

Responsibilities

• Develop, implement, and oversee the project C&Q strategy across the lifecycle.
• Coordinate engineering, construction, automation, QA, operations and vendors to ensure timely C&Q progress.
• Lead and mentor the Client C&Q team to promote a high-performance culture.
• Review and archive C&Q documents, reports, and executed protocols.

Skills

C&Q Leadership

GMP Knowledge

Project Management

Cross-functional Leadership

Job description

Senior C&Q Lead – US, Ohio – Initial 12-Month Contract – Life Sciences

Be part of a next-generation pharmaceutical project that's transforming how medicines are made.

We're supporting a major new-build facility in Ohio, a multi-billion-dollar investment designed to push the boundaries of science and engineering. We're looking for a Senior C&Q Lead to support this project and help deliver this world-class program.

What You'll Deliver

• Develop, implement, and oversee the project C&Q strategy, ensuring alignment with business, quality, GMP, and safety requirements.
• Act as a key liaison between engineering, construction, automation, QA, operations, and vendors to ensure timely C&Q progress and decisions.
• Lead, mentor, and develop the Client C&Q team, promoting a right-first-time, collaborative, and high-performance culture.
• Review, approve, and ensure effective archiving of C&Q documents, reports, and executed protocols.

What you'll need

• Extensive experience in Commissioning & Qualification within GMP regulated industries (pharmaceutical/biotech), including large capital projects.
• Demonstrated expertise across the full C&Q lifecycle (DQ, FAT, SAT, IQ/IV, OQ/OV, PQ/PPQ) with strong knowledge of GMP, regulatory requirements, and validation standards.
• Proven leadership experience managing multidisciplinary teams and contractor organizations in complex project environments.
• Strong project management capability, including planning, scheduling, risk management, and delivery against scope, budget, and timelines.