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
FAQs
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