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- Tasks: Lead GCP compliance activities and conduct audits to ensure quality in clinical trials.
- Company: Join a mid-sized pharmaceutical company with a diverse portfolio in Oncology and Neurology.
- Benefits: Enjoy a hybrid work model, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact on patient safety and data integrity in clinical research.
- Qualifications: Bachelor’s degree required; experience in clinical research and quality assurance preferred.
- Other info: Collaborate with global teams and enhance your career in a dynamic environment.
The predicted salary is between 36000 - 60000 £ per year.
An exciting role to join a mid-sized Pharmaceutical business with an extensive portfolio across the Oncology, Neurology and Pain therapy areas. The Associate Director, GCP Quality Assurance works within the Global Clinical Quality Assurance (CQA) team to conduct GCP compliance activities. The position will manage cross-functional relationships with internal and external stakeholders and be the Lead Quality Assurance representative to clinical teams on assigned trials. This is a high-visibility position with great impact potential.
What are we looking for?
- Educated to a Bachelor’s degree in an associated functional discipline, advanced degree preferred
- Demonstrated experience in Clinical research/operations/data management or related area.
- Demonstrated experience in Clinical Quality Assurance Health Authority inspection management
Main duties/responsibilities
- Representing CQA at internal, cross functional team meetings
- Supporting the training and development of CQA colleagues
- Proactively provide GCP QA support for clinical development activities to protect patient safety & well being, maintain data integrity, and support operational excellence
- Independently conduct Clinical Investigator Site Audits, GCP Document Audits (Clinical Study Reports and Trial Master Files), internal Process Audits and Vendor/System audits
- Acting as CQA Lead for clinical studies, drafting and managing Audit Plans and Audit reports
- Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to clinical teams
- Manage health authority inspections preparation activities and provide leadership and oversight during inspections
- Review and provide input to clinical documentation (e.g. protocols, study reports, IBs, ICFs)
- Compile and analyze audit metrics to communicate trends to business groups
- Conduct GCP training sessions for business groups
Working relationships:
- Internal partners including: QA UK colleagues and management, International CQA colleagues and management, Local and global clinical operations, and R&D stakeholders
- External partners including: Industry forums and Global Quality Assurance peers, Quality and operational representatives of strategic partner organisations (e.g. CROs)
Associate Director, Clinical Quality (GCP) in Watford employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, Clinical Quality (GCP) in Watford
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field, especially those who work in GCP. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your GCP knowledge and recent trends in clinical quality assurance. We recommend practising common interview questions with a friend to boost your confidence.
✨Tip Number 3
Showcase your experience! When you get the chance to speak with hiring managers, highlight your past successes in managing audits and inspections. We want to see how you can bring value to their team.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Associate Director, Clinical Quality (GCP) in Watford
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Associate Director, Clinical Quality role. Highlight your experience in Clinical Quality Assurance and any relevant GCP compliance activities. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your skills can contribute to our team. Be sure to mention your experience with health authority inspections and cross-functional collaboration.
Showcase Your Achievements: When detailing your experience, focus on specific achievements that demonstrate your impact in previous roles. Whether it's successful audits or training sessions you've led, we love to see quantifiable results that show your expertise.
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of getting noticed. It’s the easiest way for us to keep track of your application and ensure it reaches the right people!
How to prepare for a job interview at Cpl Life Sciences
✨Know Your GCP Inside Out
Make sure you brush up on Good Clinical Practice (GCP) guidelines and any recent updates. Being able to discuss specific compliance activities and how they relate to patient safety and data integrity will show that you're not just familiar with the theory, but you can apply it in practice.
✨Showcase Your Cross-Functional Experience
Since this role involves managing relationships across various teams, be prepared to share examples of how you've successfully collaborated with different stakeholders in the past. Highlight any experience you have in training or supporting colleagues, as this will demonstrate your leadership potential.
✨Prepare for Inspection Scenarios
Given the focus on health authority inspections, think about how you would handle a mock inspection. Be ready to discuss your approach to preparing for inspections and how you’ve led teams through them in the past. This will illustrate your capability to manage high-pressure situations effectively.
✨Bring Data to the Table
Compile some metrics or trends from your previous audits that you can discuss during the interview. Showing that you can analyse audit results and communicate them effectively will highlight your analytical skills and your commitment to ongoing quality improvement.
