Associate Director Quality Assurance (GCP)

Fusion Group

United Kingdom

À distance

GBP 70 000 - 90 000

Plein temps

14 jours+

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Avantages offerts par ce poste

Flexible remote working
Opportunity for travel
Collaborative team environment

Résumé du poste

A growing Contract Research Organisation seeks an Associate Director, Quality Assurance to lead GCP compliance across European operations. This remote role requires proven QA experience in clinical research, strong knowledge of GCP, and excellent communication skills. The successful candidate will influence quality culture, lead audits, and partner with global teams while ensuring regulatory compliance. A collaborative and agile team awaits you.

Qualifications

  • 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.

Responsabilités

  • 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.

Connaissances

GCP compliance
Quality Assurance oversight
Clinical research
Strong communication

Description du poste

Associate Director Quality Assurance (GCP)
Associate Director Quality Assurance (GCP)

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Specialist Life Science Recruiter & Talent Partner

Associate Director, Quality Assurance – Full-Service CRO (Europe)

Location: Remote UK

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.

Seniority level
  • Seniority level
    Mid-Senior level
Employment type
  • Employment type
    Full-time
Job function
  • Job function
    Quality Assurance and Project Management
  • Industries
    Biotechnology Research and Pharmaceutical Manufacturing

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Associate Director, Regulatory Affairs (m/f/x)*

Loughborough, England, United Kingdom 4 days ago

Associate Director/Director, Regulatory Affairs (EU- or UK-based) (EDG-2025056)
Senior Quality Assurance Manager - Coke and Refinery

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