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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 and knowledge of GCP regulations required.
- 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. This will not only help you in interviews but also demonstrate your commitment to maintaining high-quality standards 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 the position.
✨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 🫡
Tailor Your CV: Make sure your CV highlights your extensive QA experience within a CRO or clinical research facility. Emphasise your knowledge of GCP, CTIMPs, and UK clinical trial regulations to align with the job requirements.
Craft a Compelling Cover Letter: In your cover letter, express your passion for mental health and psychedelic research. Discuss how your leadership and communication skills can contribute to maintaining high-quality standards at Clerkenwell Health.
Showcase Relevant Experience: Provide specific examples of your experience managing audits, CAPAs, and QMS processes. Highlight any formal GCP training or auditing certification you possess, as this will strengthen your application.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors. A polished application reflects your attention to detail, which is crucial for a Quality Assurance Manager 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 managed audits.
✨Demonstrate Knowledge of Regulations
Familiarise yourself with the latest GCP, GDPR, and UK clinical trial regulations. During the interview, confidently discuss how you have applied this knowledge in previous roles to maintain high-quality standards.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills in managing CAPA processes and conducting audits. Think of real-life situations where you successfully navigated challenges and be ready to share those stories.
✨Emphasise Leadership and Collaboration Skills
As a QA Manager, strong leadership and communication skills are crucial. Prepare to discuss how you've led teams, engaged stakeholders, and collaborated cross-functionally to enhance trial readiness and regulatory strategy.
