Quality Assurance and Regulations Officer

HIRANI; Belfast City District; On-site; GBP 55,000 - 75,000; Full time

Job summary

Northern Ireland Clinical Research Facility (NICRF) seeks a Quality Assurance and Regulations Officer to lead the quality assurance and regulatory compliance function. The post-holder will shape governance, influence practice across NICRF and partner organisations, and ensure alignment with regulatory requirements.

The role will initially be based in NICRF and is planned to relocate to the iREACH Health Building at Belfast City Hospital site, expected to be operational early 2027.

Qualifications

• Degree in Clinical or Life Science.
• Experience and/or certification in Quality Assurance or Quality Management.
• Reviewing, enhancing and implementing administrative procedures and practices relating to quality assurance.
• Experience of audit and implementation of quality initiatives
• Experience of successful project management
• Advanced IT skills including experience of Microsoft Office software applications.
• Knowledge and understanding of the policy and practices relevant to the role, including Good Clinical Practice, Medicines for Human Use (Clinical Trials) Regulations and Research Governance, together with the ability to disseminate the knowledge and information.
• Manage Consent

Responsibilities

• Assume overall responsibility for the quality assurance and regulatory compliance function.
• Provide expert leadership and influence practice across NICRF and partner organisations.
• Lead development, implementation and continuous improvement of QA and regulatory systems.
• Ensure alignment with University, Trust and national regulatory requirements.
• Influence research governance and regulatory compliance across the School and partners.

Skills

Quality Assurance

Quality Management

Audit experience

Project management

Regulatory compliance

IT skills

Education

Degree in Clinical or Life Science

Tools

Microsoft Office

Job description

Quality Assurance and Regulations Officer

The Quality Assurance and Regulations Officer will assume overall responsibility for the quality assurance and regulatory compliance function within the Northern Ireland Clinical Research Facility (NICRF). They will lead and be accountable for the development, implementation and continuous improvement of quality assurance and regulatory systems, ensuring that all standards, policies and processes are robust, compliant and aligned to best practice.

The post-holder will play a key strategic role, providing expert leadership, and influencing practice across NICRF and partner organisations, ensuring alignment with University, Trust and national regulatory requirements. The role will also influence research governance, quality standards and regulatory compliance across the School and partner organisations.

The post will initially be based in the NICRF but will be relocated to the iREACH Health Building at the Belfast City Hospital site, which is due to be operational early 2027.

About the person:

The successful candidate must have, and your application should clearly demonstrate that you meet the essential criteria and where appropriate meet the desirable criteria.

Degree in Clinical or Life Science.

Relevant experience to include:

Experience and/or certification in Quality Assurance or Quality Management.

Reviewing, enhancing and implementing administrative procedures and practices relating to quality assurance.

Experience of audit and implementation of quality initiatives

Experience of successful project management

Advanced IT skills including experience of Microsoft Office software applications.

Knowledge and understanding of the policy and practices relevant to the role, including Good Clinical Practice, Medicines for Human Use (Clinical Trials) Regulations and Research Governance, together with the ability to disseminate the knowledge and information.

Manage Consent