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For Companies At a Glance
- Tasks: Lead quality assurance efforts, ensuring compliance with GCP and global standards.
- Company: Join a dynamic organization in the clinical development sector making a real impact.
- Benefits: Enjoy a hybrid work model with one day in the office per week.
- Why this job: Be at the forefront of quality management and regulatory compliance in clinical trials.
- Qualifications: Bachelor’s degree in life sciences and 5+ years of GCP-focused quality assurance experience required.
- Other info: Ideal for those passionate about maintaining high standards in clinical development.
The predicted salary is between 48000 - 72000 £ per year.
Job Description
Job Title: Quality Assurance Manager
Location: London, UK
Type: 6-12 month Contract, Full-time, Hybrid (1 day in office p/w)
About the Job
We are collaborating with a dynamic organization in the clinical development sector to identify a skilled Manager of Quality Assurance. This critical role is essential to ensuring compliance with global quality standards, maintaining excellence in quality systems, and driving audit readiness and inspection outcomes. A key focus of this role is on Good Clinical Practice (GCP) compliance, so candidates must have significant prior experience in GCP, with less emphasis on other GxP areas.
About the Role
As a Manager of Quality Assurance, you will play a pivotal role in maintaining the Quality Management System (QMS), overseeing audit activities, and supporting quality training initiatives. This position involves partnering with cross-functional teams and external stakeholders to ensure adherence to GCP and regulatory requirements.
Key Responsibilities:
Quality Systems Oversight:
- Manage and update QMS documents, including SOPs, policies, and templates, ensuring compliance with GCP and global regulations.
- Track and address deviations, implement corrective actions, and maintain quality logs.
Audit Coordination and Support:
- Schedule, coordinate, and track audits (internal and external) with a focus on GCP compliance, ensuring findings are resolved efficiently.
- Review audit reports, oversee corrective and preventative actions (CAPAs), and ensure documentation integrity.
Inspection Readiness and Compliance:
- Prepare teams for regulatory inspections, providing training and site support as needed, particularly for GCP-related requirements.
- Address inspection findings with timely and appropriate responses.
Training and Advisory:
- Deliver foundational training on quality and regulatory topics to staff, with emphasis on GCP principles.
- Provide quality-related guidance to project teams, fostering a culture of compliance.
Your Profile
- Bachelor’s degree in life sciences or a related field.
- At least 5 years of experience in quality assurance within the clinical or pharmaceutical industry, with the majority of this experience focused on GCP.
- Strong understanding of GCP and global regulatory requirements.
- Excellent organizational skills, with the ability to manage multiple priorities.
- Effective communicator with the ability to influence and collaborate across teams.
This role is well-suited to candidates with substantial GCP expertise and a strong commitment to ensuring compliance in clinical development.
Quality Assurance Manager (Contract, GCP) employer: Morgan Prestwich - Life Science & Healthcare Executive Search
Contact Detail:
Morgan Prestwich - Life Science & Healthcare Executive Search Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Manager (Contract, GCP)
✨Tip Number 1
Make sure to highlight your specific experience with Good Clinical Practice (GCP) in any conversations or networking opportunities. This role emphasizes GCP compliance, so showcasing your expertise will set you apart.
✨Tip Number 2
Familiarize yourself with the latest global regulatory requirements related to GCP. Being knowledgeable about current standards will demonstrate your commitment to quality assurance and compliance during interviews.
✨Tip Number 3
Network with professionals in the clinical development sector, especially those who have experience in quality assurance roles. Engaging with industry peers can provide valuable insights and potentially lead to referrals.
✨Tip Number 4
Prepare to discuss specific examples of how you've managed audit activities and addressed compliance issues in previous roles. Concrete examples will help illustrate your problem-solving skills and readiness for this position.
We think you need these skills to ace Quality Assurance Manager (Contract, GCP)
Some tips for your application 🫡
Highlight GCP Experience: Make sure to emphasize your significant experience in Good Clinical Practice (GCP) within your CV and cover letter. Provide specific examples of how you've ensured compliance and maintained quality systems in previous roles.
Tailor Your Application: Customize your CV and cover letter to align with the job description. Focus on the key responsibilities mentioned, such as managing QMS documents and coordinating audits, to demonstrate that you are a perfect fit for the role.
Showcase Communication Skills: Since effective communication is crucial for this role, include examples in your application that illustrate your ability to influence and collaborate with cross-functional teams. Highlight any training or advisory roles you've undertaken.
Proofread Your Documents: Before submitting your application, thoroughly proofread your CV and cover letter for any errors or inconsistencies. A polished application reflects your attention to detail, which is essential for a Quality Assurance Manager.
How to prepare for a job interview at Morgan Prestwich - Life Science & Healthcare Executive Search
✨Showcase Your GCP Expertise
Make sure to highlight your extensive experience with Good Clinical Practice (GCP) during the interview. Prepare specific examples of how you've ensured compliance in previous roles, as this will demonstrate your suitability for the position.
✨Understand the Quality Management System (QMS)
Familiarize yourself with the key components of a Quality Management System. Be ready to discuss how you have managed and updated QMS documents in the past, and how you ensure adherence to global regulations.
✨Prepare for Audit Scenarios
Anticipate questions related to audit coordination and support. Think of instances where you successfully managed audits or resolved findings, and be prepared to explain your approach to corrective actions and maintaining quality logs.
✨Emphasize Communication Skills
Since the role involves collaboration with cross-functional teams, be prepared to discuss how you effectively communicate and influence others. Share examples of how you've delivered training or provided guidance on quality-related topics.
