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

Quality Assurance (GCP) Manager

York 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 with a supportive culture.
  • Why this job: Shape the future of clinical research while working in a compassionate and collaborative environment.
  • Qualifications: Extensive QA experience in clinical research, knowledge of GCP, and strong leadership skills required.
  • 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

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 industry peers 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 your ability to engage stakeholders effectively will resonate well with the hiring team.

We think you need these skills to ace Quality Assurance (GCP) Manager

Extensive QA experience in Clinical Research
In-depth knowledge of GCP and UK clinical trial regulations
Experience with CAPA management
Strong leadership skills
Excellent communication skills
Stakeholder engagement
Experience in developing and maintaining Quality Management Systems (QMS)
Proficiency in conducting internal audits
Ability to manage vendor/system assessments
Experience hosting sponsor audits and regulatory inspections
Formal GCP training and auditing certification
Understanding of GDPR compliance
Risk assessment skills
Collaboration skills across cross-functional teams

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 work managing audits, CAPAs, and QMS processes. This will demonstrate your capability to lead the QA function effectively.

Highlight Certifications: If you have formal GCP training and 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 GCP, GDPR, and UK clinical trial regulations. During the interview, confidently discuss how these regulations impact quality management and how you have navigated them in past roles.

✨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 resolved issues and be ready to share those stories.

✨Emphasise Leadership and Collaboration Skills

Since this role involves leading the QA function and collaborating cross-functionally, be sure to provide examples of your leadership style and how you've effectively engaged stakeholders in previous positions.

Quality Assurance (GCP) Manager
Clerkenwell Health
C
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