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- Tasks: Lead and manage Clinical Quality Assurance activities to ensure compliance with GCP standards.
- Company: Accession Therapeutics, a dynamic clinical-stage company in Oxford.
- Benefits: Competitive salary, pension, private health insurance, and gym membership.
- Other info: Office-based role with some remote work and travel opportunities.
- Why this job: Make a real impact in the pharmaceutical industry while developing your career.
- Qualifications: 5+ years in GCP QA with strong communication and collaboration skills.
The predicted salary is between 60000 - 80000 £ per year.
Accession Therapeutics Limited, a clinical-stage company located on the ARC North Business Park in Oxford, is seeking a full-time QA GCP Associate Director / Senior Manager (title depending on experience) to oversee and manage Clinical Quality Assurance activities. The successful candidate will demonstrate strong expertise in Good Clinical Practice (GCP), with the strategic foresight and vision required to lead and develop the Quality Assurance department, especially as the company navigates a changing industry landscape.
Key Responsibilities
- Implement and co-ordinate clinical QA activities to ensure compliance with GCP standards;
- Ensure all clinical trial activities adhere to GCP regulations and internal procedures;
- Develop and manage a risk-based audit programme, overseeing GCP audit activities internally, at vendors and at clinical sites;
- Supervise and provide oversight for clinical QA consultants and third-party organizations;
- Act as the Clinical QA Lead in preparation for regulatory inspections and manage post-inspection follow-up;
- Monitor and track Key Performance Indicators (KPIs) for the reporting of Quality Metrics;
- Undertake additional assignments, as directed by the Head of Quality and Strategy.
Essential Qualifications and Skills
- Extensive GCP QA experience and a thorough understanding of Clinical Trial Applications (CTAs) and Investigational New Drug Applications (INDs);
- Expert knowledge of applicable regulations;
- Proven ability to meet deadlines and manage time efficiently;
- Strong communication skills;
- Ability to collaborate effectively within cross-functional project teams;
- Exceptional attention to detail.
Person Specification
- BSc degree or equivalent qualification;
- At least 5 years’ experience in Quality Assurance, specifically GCP, within the pharmaceutical or biopharmaceutical industry.
The position is primarily office-based, with some opportunity for remote work; occasional travel will also be required. Accession offers a good salary and company benefits including pension, private health insurance, life insurance and subsidised local gym membership. Accession Therapeutics Limited is an Equal Opportunities employer.
QA GCP Senior Manager/ QA GCP Associate Director employer: Research Quality Association (RQA)
Contact Detail:
Research Quality Association (RQA) Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA GCP Senior Manager/ QA GCP Associate Director
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work in QA or GCP. A friendly chat can lead to insider info about job openings that might not even be advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your GCP knowledge and recent industry trends. We recommend practising common interview questions with a friend or even in front of the mirror to boost your confidence.
✨Tip Number 3
Showcase your expertise! During interviews, share specific examples of how you've implemented GCP standards or managed audits. This will demonstrate your hands-on experience and strategic thinking.
✨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 QA GCP Senior Manager/ QA GCP Associate Director
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your extensive GCP QA experience and any relevant qualifications. We want to see how your background aligns with the role, so don’t be shy about showcasing your skills in managing clinical QA activities!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for the QA GCP Senior Manager/Associate Director role. Share specific examples of your past experiences that demonstrate your strategic foresight and leadership abilities.
Showcase Your Communication Skills: Strong communication is key in this role, so make sure your application reflects that. Whether it’s through clear language in your CV or a well-structured cover letter, we want to see how you can effectively convey your ideas and collaborate with teams.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re proactive and keen to join our team at Accession Therapeutics!
How to prepare for a job interview at Research Quality Association (RQA)
✨Know Your GCP Inside Out
Make sure you brush up on your Good Clinical Practice knowledge. Be ready to discuss specific regulations and how they apply to clinical trials. This shows that you’re not just familiar with the terms, but you truly understand their implications in real-world scenarios.
✨Showcase Your Leadership Skills
As a QA GCP Senior Manager or Associate Director, you'll need to demonstrate your ability to lead teams and manage projects. Prepare examples of how you've successfully overseen QA activities or led audits in the past. Highlight your strategic foresight and how you've navigated challenges in previous roles.
✨Prepare for Regulatory Inspections
Since you'll be acting as the Clinical QA Lead during inspections, think about your experiences with regulatory bodies. Be ready to discuss how you prepared for past inspections and what follow-up actions you took. This will show your proactive approach and attention to detail.
✨Understand the Company’s Vision
Research Accession Therapeutics and understand their mission and values. Be prepared to discuss how your experience aligns with their goals, especially as they navigate a changing industry landscape. This demonstrates your genuine interest in the company and its future.