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- Tasks: Lead quality assurance for clinical trials, ensuring compliance and managing audits.
- Company: Clerkenwell Health is a pioneering Clinical Research Organisation focused on mental health and psychedelic research.
- Benefits: Enjoy remote work flexibility and be part of an innovative team.
- Why this job: Shape the future of clinical research in a supportive and dynamic environment.
- Qualifications: Extensive QA experience in clinical research, with strong knowledge of GCP and UK regulations.
- Other info: Join a passionate team dedicated to compassion and collaboration.
The predicted salary is between 36000 - 60000 £ per year.
We're Hiring: Quality Assurance Manager
Location: Remote | Full-time, Permanent
Sector: Clinical Research / Life Sciences
Clerkenwell Health is a purpose-built Clinical Research Organisation (CRO) and Clinical Research Facility (CRF) focused on innovation and integrity in mental health and psychedelic research. We’re growing – and we’re looking for an experienced Quality Assurance Manager to join us in shaping the future of clinical research.
About the Role
This is a critical role for maintaining the highest quality standards across our clinical trials, ensuring compliance with GCP, GDPR, and international regulations. You’ll lead the QA function across both our CRO and CRF, manage audits and inspections, drive CAPA processes, and support the development of a robust Quality Management System (QMS).
Key Responsibilities
- Lead QA oversight across clinical and operational activities
- Develop and maintain the QMS, SOPs, and document control processes
- Conduct internal audits and vendor/system assessments
- Host and manage sponsor audits and regulatory inspections
- Ensure compliance with GCP, GDPR, and UK clinical trial regulations
- Support quality training, risk assessments, and CAPA management
- Collaborate cross-functionally on trial readiness and regulatory strategy
What We’re Looking For
- Extensive QA experience within a CRO or clinical research facility
- In-depth knowledge of GCP, CTIMPs, and UK clinical trial regulations
- Proven experience managing audits, CAPAs, and QMS processes
- Strong leadership, communication, and stakeholder engagement skills
- Formal GCP training & auditing certification would be advantageous
Why Join Us?
At Clerkenwell Health, we value compassion, collaboration, innovation, and integrity. You’ll be part of a passionate team pioneering new approaches to mental health research in a dynamic and supportive environment.
Quality Assurance (GCP) Manager employer: Clerkenwell Health
Contact Detail:
Clerkenwell Health Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance (GCP) Manager
✨Tip Number 1
Familiarise yourself with the latest GCP guidelines and UK clinical trial regulations. Being well-versed in these areas will not only boost your confidence but also demonstrate your commitment to quality assurance in clinical research.
✨Tip Number 2
Network with professionals in the clinical research field, especially those who have experience in QA roles. Engaging in conversations can provide insights into the role and may even lead to referrals or recommendations.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully managed audits and CAPA processes in your previous roles. Highlighting your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Showcase your leadership and communication skills during any interactions with us. As a QA Manager, you'll need to effectively engage with various stakeholders, so demonstrating these abilities early on is crucial.
We think you need these skills to ace Quality Assurance (GCP) Manager
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Quality Assurance Manager position. Understand the key responsibilities and required qualifications to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasise your extensive QA experience within a CRO or clinical research facility. Provide specific examples of how you've managed audits, CAPAs, and QMS processes in previous roles.
Showcase Your Knowledge: Demonstrate your in-depth knowledge of GCP, CTIMPs, and UK clinical trial regulations in your application. Mention any formal GCP training or auditing certifications you possess, as these will strengthen your candidacy.
Craft a Compelling Cover Letter: Write a personalised cover letter that reflects your passion for mental health research and your alignment with Clerkenwell Health's values. Highlight your leadership skills and ability to collaborate cross-functionally, as these are crucial for the role.
How to prepare for a job interview at Clerkenwell Health
✨Showcase Your QA Expertise
Make sure to highlight your extensive experience in Quality Assurance, particularly within a CRO or clinical research facility. Be prepared to discuss specific examples of how you've ensured compliance with GCP and other regulations in past roles.
✨Demonstrate Leadership Skills
Since this role requires strong leadership, think of instances where you've successfully led a team or project. Share how you managed audits, CAPAs, and developed QMS processes, showcasing your ability to drive quality standards.
✨Prepare for Technical Questions
Expect questions related to GCP, GDPR, and UK clinical trial regulations. Brush up on these topics and be ready to explain how you would handle compliance issues or improve existing processes in the organisation.
✨Emphasise Collaboration
This role involves cross-functional collaboration, so be ready to discuss how you've worked with different teams in the past. Highlight your communication skills and how you've engaged stakeholders to achieve common goals.
