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Job type: Permanent

Discipline: Senior/Director & VP

Location: United Kingdom

Are you a dedicated individual looking to put your QA expertise to work fully flexibly in a remote position?

̽��ϼ� is seeking an AD of Technology Quality Assurance to join a dynamic team focused on ensuring compliance and quality in clinical trial laboratory technology systems. This role involves overseeing audits, managing quality events, and collaborating with cross-functional teams to maintain and improve IT quality processes. The position offers a remote working opportunity with occasional travel within the EMEA region.

Responsibilities:

Lead the planning, putting into place and reporting of Clinical Trial Laboratory Technology Systems audits, ensuring adherence to GxP standards, GAMP principles, and internal SOPs.
Manage and lead a team of technology auditors and specialists.
Evaluate audit findings, prepare reports, and ensure corrective and preventive actions are implemented effectively.
Oversee and maintain electronic quality management systems (eQMS) and support the audit lifecycle.
Review and approve investigations, root cause analyses, and corrective action plans, ensuring timely closure of quality events.
Stay updated on regulatory developments and ensure compliance with industry best practices.
Collaborate with IT, QA, and business functions to validate new systems and enhance existing IT quality processes.
Provide guidance on regulatory controls, compliance status, and continuous process improvements.
Lead and support quality assurance initiatives and projects.
Train new Quality Assurance staff and provide compliance guidance to operational teams.
Represent the Technology QA team during audits and client meetings as needed.

Key Skills and Requirements:

Strong experience in Quality Assurance within the CRO, pharmaceutical, or biotechnology industries.
Proficiency in auditing and compliance of computer systems in FDA-regulated environments, including clinical trials.
Expertise in Computer Systems Validation (CSV) and software validation methodologies.
Familiarity with lab instrumentation workflows and regulated equipment maintenance programs.
Knowledge of GxP regulations, 21 CFR Part 11, GAMP guidelines, and data integrity requirements.
Experience conducting internal and third-party audits and managing organizational responses.
Strong leadership skills with experience in direct line management.
Excellent understanding of clinical trial processes and quality subsystems.

If you are having difficulty in applying or if you have any questions, please contact Ingrid Aymes at i.aymes@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

̽��ϼ� is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ̽��ϼ� is acting as an Employment Agency in relation to this vacancy.

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