C&Q Lead

CQV Lead
Role
We are seeking an experienced CQV professional to take on a leadership and oversight position within a GMP pharmaceutical project currently running behind schedule. This is a strategic role, not execution-focused, where you will act as the internal CQV lead, driving delivery through a third-party provider. You will play a key role in stabilising the project, ensuring alignment to timelines, quality standards, and regulatory expectations, while providing clear direction and governance across all CQV activities.

Responsibilities

• Act as the site CQV lead, providing strategic oversight and decision-making
• Manage and coordinate a third-party CQV vendor, ensuring performance and delivery
• Review and approve CQV documentation (protocols, reports, deviations), ensuring GMP compliance
• Drive schedule adherence and support recovery planning on a delayed project
• Oversee commissioning and qualification activities across:
• HVAC systems
• Cleanroom and room qualification
• Downflow booths and safety cabinets (including specialist units)
• Basic equipment commissioning
• Ensure effective stakeholder coordination between internal teams and external partners
• Maintain high standards of quality, compliance, and execution control
• Provide clear reporting and progress visibility to project stakeholders