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For Companies At a Glance
- Tasks: Manage quality systems, oversee audits, and ensure GCP compliance.
- Company: Join a dynamic organisation in the clinical development sector.
- Benefits: Enjoy a hybrid work model with one day in the office per week.
- Why this job: Make a real impact on quality assurance in clinical trials while collaborating with diverse teams.
- Qualifications: Bachelor’s degree in life sciences and 5+ years of GCP-focused quality assurance experience required.
- Other info: This is a contract role lasting 6-12 months, perfect for those passionate about compliance.
The predicted salary is between 48000 - 72000 £ per year.
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
Network with professionals in the clinical development sector, especially those who have experience in GCP compliance. Attend industry events or webinars to connect with potential colleagues and learn more about the latest trends and challenges in quality assurance.
✨Tip Number 2
Familiarise yourself with the specific GCP guidelines and regulations that are relevant to the role. This will not only enhance your knowledge but also demonstrate your commitment to compliance during any discussions with our team.
✨Tip Number 3
Prepare to discuss your previous experiences in managing quality systems and audits. Be ready to share specific examples of how you've successfully addressed GCP compliance issues and improved processes in your past roles.
✨Tip Number 4
Showcase your ability to collaborate with cross-functional teams by highlighting any past projects where you worked closely with different departments. This will illustrate your teamwork skills and your understanding of the importance of a cohesive approach to quality assurance.
We think you need these skills to ace Quality Assurance Manager (Contract, GCP)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in quality assurance, particularly focusing on Good Clinical Practice (GCP). Use specific examples from your previous roles that demonstrate your expertise and achievements in this area.
Craft a Compelling Cover Letter: In your cover letter, express your passion for quality assurance and compliance in the clinical development sector. Mention how your background aligns with the key responsibilities of the role, especially your experience with GCP and audit readiness.
Highlight Relevant Skills: When writing your application, emphasise skills that are crucial for the role, such as organisational abilities, communication skills, and experience in training staff on quality and regulatory topics. Make sure to provide concrete examples of how you've applied these skills in past positions.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. 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 during the interview. Be prepared to discuss specific examples of how you've ensured compliance and managed quality systems in previous roles.
✨Demonstrate Organisational Skills
Given the need to manage multiple priorities, share instances where you've successfully juggled various tasks or projects. This will show your potential employer that you can handle the demands of the role effectively.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities, especially related to audit findings or inspection readiness. Practise articulating your thought process and the steps you would take to address these situations.
✨Emphasise Communication and Collaboration
Since the role involves working with cross-functional teams, be ready to discuss how you've influenced and collaborated with others in past positions. Highlight any training initiatives you've led, particularly those focused on GCP compliance.
