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- Tasks: Lead GCP quality assurance activities and ensure clinical trials meet top regulatory standards.
- Company: Join Planet Pharma, a leader in clinical quality assurance with a focus on innovation.
- Benefits: Competitive salary, professional development, and opportunities for international travel.
- Why this job: Make a real impact on clinical trials and drive quality improvements in a dynamic environment.
- Qualifications: 5+ years in Clinical Quality Assurance with strong knowledge of GCP and regulatory requirements.
- Other info: Collaborative culture with excellent career growth opportunities and a commitment to quality.
The predicted salary is between 48000 - 72000 £ 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 Belfast employer: Planet Pharma
Contact Detail:
Planet Pharma Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Quality Assurance Manager – GCP in Belfast
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical quality assurance field. Attend industry events or webinars, and don’t be shy about introducing yourself. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for interviews by brushing up on your GCP knowledge and regulatory standards. We recommend practising common interview questions with a friend or even in front of the mirror. The more comfortable you are, the better you’ll perform!
✨Tip Number 3
Showcase your experience with real-life examples during interviews. We want to hear about your hands-on audit delivery or how you managed CAPAs. This is your chance to shine and demonstrate your expertise!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Clinical Quality Assurance Manager – GCP in Belfast
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Clinical Quality Assurance Manager role. Highlight your experience in GCP and any relevant regulatory knowledge. We want to see how your background aligns with what we’re looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality assurance in clinical trials and how you can contribute to our team. Keep it engaging and relevant to the job description.
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use specific examples of how you’ve improved quality systems or led successful audits. We love seeing quantifiable results that demonstrate your impact.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Planet Pharma
✨Know Your GCP Inside Out
Make sure you brush up on your knowledge of ICH-GCP guidelines and global regulatory requirements. Being able to discuss these confidently will show that you're not just familiar with the standards, but that you can apply them practically in a clinical setting.
✨Showcase Your Audit Experience
Prepare specific examples of audits you've conducted or participated in. Discuss the challenges you faced, how you overcame them, and the outcomes. This will demonstrate your hands-on experience and problem-solving skills, which are crucial for this role.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle specific situations, like managing deviations or preparing for an inspection. Think through your past experiences and be ready to articulate your thought process and the steps you would take in these scenarios.
✨Highlight Your Communication Skills
Since this role involves working cross-functionally, be prepared to discuss how you've effectively communicated with different teams in the past. Share examples that showcase your ability to influence and build credibility quickly, as well as your adaptability in fast-paced environments.
