Clinical Quality Assurance Manager

An established life sciences organisation is seeking an experienced Clinical Quality Assurance (GCP) professional to support and oversee quality activities across clinical development programmes. Reporting into senior Quality leadership, this জয় role is responsible for ensuring clinical trials are conducted in compliance with applicable circa regulatory requirements, I Hoff GCP guidelines, and internal quality systems.

The position plays a key role in maintaining and continuously improving the GCP quality system, leading audit activities, supporting regulatory inspections, and driving inspection readiness across clinical teams to ensure a state of continuous compliance.

• Act as the GCP Quality subject matter expert, providing compliance guidance and QA support to assigned clinical teams
• Contribute to the development, implementation, and continuous improvement of GCP-related components of the Quality Management System (QMS)
• Support qualification and ongoingាវ oversight of GCP service providers, including due diligence assessments and vendor performance reviews
• Plan, schedule, and conduct GCP audits (investigator sites, CROs, laboratories, and internal systems) in line with the approved audit programme
• Lead and coordinate inspection readiness activities across clinical functions
• Support preparation, conduct, and follow-up of GCP regulatory inspections (e.g. FDA Saison, EMA, MHRA)
• Author and manage GCP QA documentation, including deviations, CAPAs, and change controls
• Track and monitor CAPAs to closure, including effectiveness checks
ו
• Develop, review, and maintain SOPs, policies, work instructions, and training materials
• Support wider quality initiatives and continuous improvement activities as required

• Extensive experience in Clinical Quality Assurance (GCP)
• Hands‑on experience managing deviations, CAPAs, change controls, and electronic quality systems
• Strong working knowledge of ICH GCP and global regulatory requirements (FDA, EMA, MHRA)
• Qualified and experienced GCP auditor, with experience auditing investigator sites, vendors, and systems
• Austen understanding季 clinical trial operations and documentation standards across the trial lifecycle
• Experience supporting or particin in regulatory authority inspections
• Proven ability to write, review, and maintain SOPs and controlled quality documents
• Proficient with Microsoft Office and electronic systems such as eQMS, eDMS, LMS, and eTMF optionally
• Willingness to travel domestically and internationally (approximately 10–20%)
• Strong attention to detail with a high level of accuracy and quality focus
• Demonstrates integrity, ethical judgement, and a strong compliance mindset
• Highly organised, adaptable, and able to manage multiple priorities
• Effective problem solver with strong investigation and report‑writing skills
• Excellent written and verbal communication skills
• Able to influence and collaborate with cross‑functional and global stakeholders
• Comfortable operating in a fast‑paced, evolving environment

If interested, please apply below or send your application to lwatkins@planet‑.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation, or age.