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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 innovation.
- Benefits: Enjoy remote work flexibility and be part of a supportive, dynamic team.
- Why this job: Shape the future of clinical research while working in a compassionate and innovative environment.
- Qualifications: Extensive QA experience in clinical research, with strong knowledge of GCP and UK regulations.
- Other info: Join us in making a real impact in mental health research.
The predicted salary is between 36000 - 60000 £ per year.
We’re hiring for a Quality Assurance Manager. Location: Remote | Full-time, Permanent.
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 understand the role better but also demonstrate your commitment to compliance during any discussions.
✨Tip Number 2
Network with professionals in the clinical research field, especially those who have experience in QA roles. Engaging with them can provide insights into the company culture and expectations, which can be invaluable during interviews.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully managed audits and CAPA processes in your previous roles. Being able to articulate your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Showcase your leadership and communication skills by preparing to discuss how you've collaborated with cross-functional teams in the past. Highlighting these experiences will align well with the collaborative nature of the role at Clerkenwell Health.
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 previous roles where you managed audits, CAPAs, and QMS processes. This will demonstrate your capability to lead QA oversight effectively.
Highlight Certifications: If you have formal GCP training or auditing certification, make sure to mention these in your application. This can set you apart from other candidates and show your commitment to quality assurance.
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 past experiences 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 ensure trial readiness and regulatory compliance.
