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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 excellence in quality systems and compliance.
- Qualifications: Bachelor’s degree in life sciences and 5+ years of GCP-focused quality assurance experience required.
- Other info: This is a contract position lasting 6-12 months, perfect for those seeking impactful work.
The predicted salary is between 43200 - 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: JR United Kingdom
Contact Detail:
JR United Kingdom 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. Attend industry events or webinars to connect with potential colleagues and learn about the latest trends and challenges in quality assurance.
✨Tip Number 3
Prepare to discuss specific examples from your past experience where you successfully managed quality systems or led audit activities. Highlighting your hands-on experience will make you stand out as a candidate who can hit the ground running.
✨Tip Number 4
Showcase your training abilities by preparing to discuss how you've previously delivered training on GCP principles. This will illustrate your capability to foster a culture of compliance within teams, which is crucial for this role.
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: Write a cover letter that clearly outlines your passion for quality assurance and your understanding of GCP. Mention how your skills align with the responsibilities listed in the job description, and express your enthusiasm for the role.
Highlight Relevant Experience: In your application, emphasise your experience in managing Quality Management Systems and conducting audits. Provide concrete examples of how you've ensured compliance with GCP and resolved any audit findings.
Proofread Your Application: Before submitting, carefully proofread your application materials for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in a Quality Assurance role.
How to prepare for a job interview at JR United Kingdom
✨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
Familiarise yourself with Quality Management Systems (QMS) and be ready to discuss how you have managed or updated QMS documents in the past. This knowledge is crucial for the role and will show that you are proactive about quality assurance.
✨Prepare for Audit Scenarios
Anticipate questions related to audit coordination and support. Be prepared to discuss how you've handled audits, resolved findings, and implemented corrective actions. This will illustrate your ability to maintain audit readiness.
✨Emphasise Training and Collaboration Skills
Since the role involves delivering training and collaborating with cross-functional teams, be ready to share your experiences in these areas. Highlight any successful training initiatives you've led and how you've fostered a culture of compliance within teams.
