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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.
- Why this job: Make a real impact in the pharmaceutical industry while developing your career.
- Qualifications: 5+ years of GCP QA experience and strong regulatory knowledge required.
- Other info: Office-based role with some remote work and travel opportunities.
The predicted salary is between 36000 - 60000 £ 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;
- Ability to collaborate effectively within cross-functional project teams;
- Exceptional attention to detail.
Person Specification
- 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.
To apply for this position please send a letter of application (this is essential) and a copy of your C.V.
QA GCP SENIOR MANAGER / QA GCP ASSOCIATE DIRECTOR employer: Accession Therapeutics Limited
Contact Detail:
Accession Therapeutics Limited 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 at Accession Therapeutics or similar companies. A friendly chat can sometimes lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on GCP regulations and recent changes in the industry. We recommend creating a cheat sheet of key points to discuss, so you can showcase your expertise and strategic vision during the interview.
✨Tip Number 3
Don’t just wait for job postings! Keep an eye on our website and apply directly through it. This shows initiative and can help you stand out from the crowd. Plus, we love seeing candidates who are proactive!
✨Tip Number 4
Follow up after your interview with a thank-you email. It’s a simple gesture that can leave a lasting impression. Mention something specific from your conversation to remind them why you’re the perfect fit for the role.
We think you need these skills to ace QA GCP SENIOR MANAGER / QA GCP ASSOCIATE DIRECTOR
Some tips for your application 🫡
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Make sure to highlight your extensive GCP QA experience and how it aligns with the role. We want to see your passion for Quality Assurance and how you can contribute to our team.
Tailor Your CV: Don’t just send a generic CV! Tailor it to showcase your relevant skills and experiences that match the job description. We love seeing how your background fits with what we’re looking for, so make it easy for us!
Showcase Your Attention to Detail: In QA, attention to detail is key! Ensure your application is free from typos and errors. A polished application reflects your commitment to quality, which is exactly what we value at StudySmarter.
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you don’t miss out on any important updates. Plus, it’s super easy!
How to prepare for a job interview at Accession Therapeutics Limited
✨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 will show that you’re not just familiar with the basics, but that you can navigate the complexities of GCP with ease.
✨Showcase Your Leadership Skills
As a QA GCP Senior Manager or Associate Director, you'll need to demonstrate your ability to lead a team. Prepare examples of how you've successfully managed QA activities in the past, especially in challenging situations. Highlight your strategic foresight and vision for developing a QA department.
✨Prepare for Regulatory Inspections
Since you'll act as the Clinical QA Lead during inspections, think about your experiences with regulatory bodies. Be ready to discuss how you’ve prepared for inspections in the past and what steps you took to ensure compliance. This will show your proactive approach to quality assurance.
✨Emphasise Collaboration and Communication
This role requires effective collaboration within cross-functional teams. Think of examples where you’ve worked closely with other departments to achieve a common goal. Highlight your communication skills and how they’ve helped you manage relationships with consultants and third-party organisations.