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Clinical qa manager - interim

London
Coronado Research
Qa manager
€60,000 a year
Posted: 27 April
Offer description

We are looking for a contract QA Manager to work with a client in Central London.

We need a QA & Compliance Manager to lead and continuously strengthen quality and compliance framework across all project activities. This role is responsible for the hands‑on implementation and oversight of the Quality Management System, ensuring compliance with applicable regulatory requirements, industry standards and client expectations.

The QA & Compliance Manager will provide practical guidance to study teams, proactively manage risk, oversee audits and inspections and drive continuous improvement across the business. Acting as a key partner to operational teams and senior leadership, the role plays a critical part in maintaining inspection readiness, supporting business growth and embedding a strong quality culture throughout.


Key Responsibilities

* Quality Management System (QMS)
* Quality Assurance & Compliance
* Audits, Inspections & Continuous Improvement
* Training & Quality Culture
* Regulatory Intelligence & Reporting
* Data Protection & Governance


Qualifications and Experience

Ideal background:

* Strong years of experience in clinical research, including time spent in Quality Assurance and Compliance within a CRO, pharmaceutical or biotech environment
* Demonstrated experience developing, implementing and maintaining a Quality Management System (QMS) in a regulated clinical research setting
* Strong working knowledge of ICH‑GCP, ISO standards and applicable global regulatory requirements
* Proven experience managing clinical audits, vendor audits and regulatory inspections
* Hands‑on experience investigating quality issues, deviations and non‑conformances, including leading root cause analysis and CAPA development
* Experience assessing and managing compliance risks related to new services, technologies, or business initiatives
* Demonstrated experience providing QA guidance and oversight to cross‑functional clinical teams
* Prior experience acting as, or supporting, a Data Protection Officer (DPO) role and ensuring compliance with data protection legislation (e.g. GDPR) preferred
* Experience developing and delivering quality and compliance training programs
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