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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 organisation 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 part of a crucial role that drives quality and compliance in clinical trials.
- Qualifications: Bachelor’s degree in life sciences and 5+ years of GCP-focused QA experience required.
- Other info: This is a contract position lasting 6-12 months, perfect for gaining valuable industry experience.
The predicted salary is between 43200 - 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.
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
Familiarise yourself with the latest GCP guidelines and regulations. Being well-versed in these standards will not only boost your confidence during interviews but also demonstrate your commitment to quality assurance in clinical development.
✨Tip Number 2
Network with professionals in the clinical development sector, especially those who have experience in GCP compliance. Engaging in conversations can provide insights into the role and may even lead to referrals or recommendations.
✨Tip Number 3
Prepare to discuss specific examples from your past experience where you successfully managed quality systems or resolved audit findings. This will showcase your practical knowledge and problem-solving skills relevant to the role.
✨Tip Number 4
Stay updated on industry trends and challenges related to GCP compliance. Showing that you are proactive about learning and adapting can set you apart as a candidate who is ready to tackle the evolving landscape of 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 GCP compliance. Use specific examples from your previous roles to demonstrate your expertise and achievements in this area.
Craft a Compelling Cover Letter: In your cover letter, express your passion for quality assurance and the clinical development sector. Mention how your background aligns with the key responsibilities of the role, especially your experience with audit coordination and training initiatives.
Highlight Relevant Skills: Emphasise skills that are crucial for the role, such as organisational abilities, communication skills, and your capacity to manage multiple priorities. Provide concrete examples of how you've successfully applied these skills in past positions.
Proofread Your Application: Before submitting your application, carefully proofread all documents to ensure there are no spelling or grammatical errors. A polished application reflects your attention to detail, which is vital in quality assurance roles.
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. Be prepared to discuss specific projects where you ensured compliance and how you handled any challenges that arose.
✨Demonstrate Organisational Skills
Since the role requires managing multiple priorities, share examples of how you've successfully juggled various tasks in previous positions. Use concrete examples to illustrate your ability to stay organised and meet deadlines.
✨Prepare for Audit Scenarios
Expect questions related to audit coordination and inspection readiness. Prepare to discuss your approach to scheduling audits, addressing findings, and implementing corrective actions. This will show your proactive mindset towards compliance.
✨Communicate Effectively
As an effective communicator, you’ll need to influence and collaborate across teams. Practice articulating your thoughts clearly and confidently, and be ready to provide examples of how you've successfully worked with cross-functional teams in the past.
