Quality Assurance (GCP) Manager
Quality Assurance (GCP) Manager

Quality Assurance (GCP) Manager

Guildford Full-Time 36000 - 60000 £ / year (est.) No home office possible
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At a Glance

  • 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 innovation and integrity in mental health research.

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

Clerkenwell Health is an exceptional employer, offering a dynamic and supportive remote work environment that fosters innovation and collaboration in the field of mental health and psychedelic research. With a strong commitment to employee growth, we provide opportunities for professional development and training, ensuring our team members are equipped to excel in their roles. Join us to be part of a passionate team dedicated to maintaining the highest quality standards in clinical research while making a meaningful impact on mental health.
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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 cross-functionally in past projects. 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

Extensive QA experience in Clinical Research
In-depth knowledge of GCP and CTIMPs
Understanding of UK clinical trial regulations
Experience in managing audits and inspections
CAPA management skills
Development and maintenance of Quality Management Systems (QMS)
Strong leadership abilities
Excellent communication skills
Stakeholder engagement expertise
Formal GCP training and auditing certification
Risk assessment capabilities
Document control process management
Cross-functional collaboration skills
Attention to detail

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.

Highlight Relevant Certifications: If you have formal GCP training and auditing certification, make sure to mention these in your application. This will demonstrate your commitment to quality assurance and compliance.

Showcase Your Achievements: Include specific examples of how you've successfully managed audits, CAPAs, and QMS processes in your previous roles. Quantifying your achievements can make your application stand out.

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

Since the role requires strong leadership and stakeholder engagement skills, prepare to discuss how you've led teams and collaborated cross-functionally. Highlight any successful projects where your leadership made a significant impact.

Quality Assurance (GCP) Manager
Clerkenwell Health
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  • Quality Assurance (GCP) Manager

    Guildford
    Full-Time
    36000 - 60000 £ / year (est.)

    Application deadline: 2027-07-01

  • C

    Clerkenwell Health

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