At a Glance
- Tasks: Lead GCP quality activities and ensure clinical trials meet top regulatory standards.
- Company: Join a dynamic pharma company focused on quality and innovation.
- Benefits: Competitive salary, professional development, and opportunities for global travel.
- Other info: Fast-paced environment with excellent career growth potential.
- Why this job: Make a real impact in clinical trials and drive continuous improvement.
- Qualifications: 5+ years in Clinical Quality Assurance with strong GCP knowledge.
The predicted salary is between 36000 - 60000 £ per year.
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
- 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.
Clinical Quality Assurance Manager – GCP in London employer: Planet Pharma
At Planet Pharma, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. As a Clinical Quality Assurance Manager, you will benefit from our commitment to employee growth through continuous training and development opportunities, while also enjoying the unique advantage of working in a dynamic environment that values quality and compliance in clinical trials. Join us in making a meaningful impact in the life sciences sector, where your expertise will be recognised and valued.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Quality Assurance Manager – GCP in London
✨Unlock Networking Opportunities
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✨Leverage Internships for Full-time Roles
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✨Tailor Your Approach
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We think you need these skills to ace Clinical Quality Assurance Manager – GCP in London
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Planet Pharma!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Planet Pharma that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Planet Pharma!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Planet Pharma, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Planet Pharma
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Planet Pharma that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Planet Pharma’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
