Commissioning & Qualification (C&Q) Lead
Core
Strategic and technical leadership for an integrated site Commissioning & Qualification (C&Q) function, ensuring facilities, utilities, equipment, and processes are commissioned, qualified, and maintained in a compliant state throughout their lifecycle in a cGMP environment.
Role type
Senior IC Commissioning & Qualification (C&Q) Lead
Builds
Compliant manufacturing facilities and processes for biotherapeutics production
Domain
Life Sciences / Biotherapeutics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, lifecycle requalification, hybrid delivery model design, change management, stakeholder engagement, digital validation platform adoption, team leadership
Preferred skills
ASTM E2500 principles knowledge, experience with TGA/FDA/PIC/S regulations, experience with Kneat or similar digital validation platforms
Technologies
Kneat, ASTM E2500
Responsibilities
Define and implement site C&Q strategy, lead and develop a high-performing C&Q organization, act as senior C&Q Subject Matter Expert for end-to-end delivery, interface between Engineering, Quality, Operations, Validation, Regulatory, and global functions, embed digitally enabled C&Q practices
Seniority
Senior, hands-on IC with strategic leadership
