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.
