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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 during interviews 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 with industry peers can provide valuable insights and may even lead to referrals for job openings at Clerkenwell Health.
✨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 help you stand out as a candidate who can effectively lead the QA function.
✨Tip Number 4
Showcase your leadership and communication skills by preparing to discuss how you've collaborated cross-functionally in past projects. This will illustrate your ability to work well within a team and support the development of a robust Quality Management System.
We think you need these skills to ace Quality Assurance (GCP) Manager
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to grasp the key responsibilities and requirements. Tailor your application to highlight your relevant experience in Quality Assurance within clinical research.
Highlight Relevant Experience: Emphasise your extensive QA experience, particularly within a CRO or clinical research facility. Provide specific examples of how you've managed audits, CAPAs, and QMS processes in your previous roles.
Showcase Your Skills: Demonstrate your strong leadership, communication, and stakeholder engagement skills in your CV and cover letter. Use concrete examples to illustrate how you've successfully collaborated cross-functionally on trial readiness and regulatory strategy.
Craft a Compelling Cover Letter: Write a personalised cover letter that reflects your passion for mental health research and your alignment with the company's values. Mention your formal GCP training and auditing certification if applicable, as this could set you apart from other candidates.
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 managed audits.
✨Demonstrate Knowledge of Regulations
Familiarise yourself with GCP, GDPR, and UK clinical trial regulations. During the interview, confidently discuss how you have applied these regulations in your previous roles and how they relate to the responsibilities of the position.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills and ability to manage CAPA processes. Think of past experiences where you successfully navigated challenges and be ready to share those stories.
✨Emphasise Leadership and Collaboration Skills
Since the role requires strong leadership and stakeholder engagement, prepare to discuss how you've led teams and collaborated cross-functionally. Share examples that demonstrate your ability to drive quality initiatives and foster teamwork.
