Planet Pharma is seeking an experienced Clinical Quality Assurance Manager (GCP) to play a pivotal role in ensuring clinical trials are conducted to the highest regulatory and quality standards. Reporting into a senior QA leader, this position provides hands‑on ownership of the GCP quality framework and acts as a trusted quality partner to clinical teams across the organisation.
You will lead core GCP quality activities including quality system oversight, audit planning and execution, and regulatory inspection readiness. This role offers the opportunity to influence quality strategy, shape inspection preparedness, and drive continuous improvement across a growing clinical portfolio.
What You’ll Be Responsible For
* Act as the GCP Quality Subject Matter Expert, providing pragmatic compliance guidance and QA support to clinical study teams.
* Support the development, maintenance, and continuous improvement of the GCP Quality Management System (QMS).
* Lead and contribute to GCP vendor qualification and oversight, including due diligence activities and performance reviews.
* Plan, schedule, and conduct GCP audits (investigator sites, CROs, laboratories, and internal systems) in line with the approved audit programme.
* Drive inspection readiness activities, partnering cross‑functionally to ensure a constant state of preparedness.
* Support regulatory authority inspections (e.g. FDA, EMA, MHRA), including preparation, conduct, and follow‑up activities.
* Author, review, and manage deviations, CAPAs, and change controls, ensuring timely closure and robust documentation.
* Track and verify the effectiveness of audit- and inspection‑related CAPAs to completion.
* Develop and maintain SOPs, policies, training materials, and work instructions in line with current regulations and industry best practice.
* Partner with Quality leadership on company‑wide quality initiatives and continuous improvement programmes.
What We’re Looking For
Education & Experience
* Degree in a life sciences discipline or equivalent industry experience (5+ years).
* Minimum 5 years’ experience in Clinical Quality Assurance (GCP) within a regulated environment.
* Proven experience managing deviations, CAPAs, change controls, and electronic quality systems.
Technical Expertise
* Strong working knowledge of ICH‑GCP and global regulatory requirements (FDA, EMA, MHRA).
* Qualified and experienced GCP auditor with hands‑on audit delivery experience.
* Solid understanding of clinical trial operations and documentation standards across the study lifecycle.
* Experience supporting or participating in GCP regulatory inspections.
* Confident author and reviewer of clinical QA SOPs and controlled documentation.
* Proficient with eQMS, eDMS, LMS, eTMF, and Microsoft Office tools.
* Willingness to travel domestically and internationally (10–20%).
What Will Make You Successful
* Exceptional attention to detail with a strong quality‑driven mindset.
* High personal integrity, professionalism, and commitment to regulatory compliance.
* Organised, adaptable, and able to manage multiple priorities in a fast‑moving environment.
* Strong problem‑solving and investigative skills, with the ability to deliver clear, evidence‑based outcomes.
* Excellent written and verbal communication skills, with confidence working cross‑functionally and globally.
* Ability to influence, build credibility quickly, and navigate competing priorities with a collaborative approach.