At a Glance
- Tasks: Lead GCP quality assurance across Europe and conduct audits.
- Company: Dynamic, growing Contract Research Organisation with a global reach.
- Benefits: Flexible remote work, significant autonomy, and career growth opportunities.
- Other info: Collaborative team environment with direct impact on operations.
- Why this job: Shape quality systems in a scaling CRO and influence the quality culture.
- Qualifications: Proven QA experience in clinical research and strong GCP knowledge.
The predicted salary is between 65000 - 80000 £ per year.
We’re representing a growing, full-service Contract Research Organisation (CRO) with an ambitious international footprint. This is an exciting opportunity to join a small but dynamic QA team where you will make a direct impact across GCP quality oversight in Europe.
The Role
As Associate Director, QA, you’ll be responsible for providing quality leadership across European operations, ensuring GCP compliance from clinical operations through to auditing activities. Working closely with stakeholders across the organisation, you’ll partner with study teams, vendors, and regulatory authorities to maintain the highest quality standards. You will report directly to the Head of QA (US), acting as the European quality lead and a trusted advisor for operational teams. This role offers significant visibility, autonomy, and the chance to help shape processes within an emerging CRO.
Key Responsibilities
- Lead and oversee GCP QA activities across European operations.
- Conduct and manage internal, vendor, and investigator site audits.
- Provide quality guidance and GCP interpretation to operational teams.
- Support inspection readiness and host regulatory inspections as required.
- Collaborate with the global QA leadership team to align processes and standards.
- Identify process improvement opportunities and contribute to the development of SOPs, training, and QA strategy.
About You
- Proven QA experience within the clinical research/CRO or pharma industry.
- Strong knowledge of GCP and European regulatory requirements.
- Hands-on experience with audits and inspection readiness.
- Confident communicator with the ability to influence across functions and geographies.
- Self-motivated and comfortable working in a small, fast-paced, and growing organisation.
Why Join?
- Be part of a collaborative, agile team where your voice matters.
- Shape quality systems in a CRO that is scaling globally.
- Work closely with US-based leadership while leading QA initiatives in Europe.
- Flexible, remote working with travel for audits and meetings.
If you’re looking for a role where you can truly influence the quality culture of an emerging CRO while keeping close to the science and operations, this is an opportunity to explore.
Associate Director Quality Assurance (GCP) employer: Fusion Group
Join a dynamic and rapidly growing pharmaceutical services company in Willington, UK, where your expertise as a Senior Quality Assurance Officer will be valued and impactful. With a strong focus on employee development, a collaborative work culture, and the opportunity to work in a hybrid environment, this role offers a unique chance to contribute to the clinical trials industry while enjoying a supportive atmosphere that prioritises quality and compliance. Be part of a team that has already surpassed its commercial targets, ensuring your efforts are recognised and rewarded.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director Quality Assurance (GCP)
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Fusion Group. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Fusion Group.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Fusion Group. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Fusion Group is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Associate Director Quality Assurance (GCP)
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Fusion Group!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Fusion Group that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Fusion Group!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Fusion Group, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Fusion Group
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Fusion Group that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Fusion Group’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
