Reference Number: JO-2109-475707
Head of Quality
Job Type: Permanent
Reporting to the Director of Quality, the Head of QA will assist in the delivery of autonomous and innovative leadership to achieve:
- Delivery of compliant Quality Systems, and development of a world-class QMS, through effective leadership of the QMS and Compliance teams;
- Effective and swift development of health interventions, and increase the Companys competitive edge in translational research;
- Delivery of a leading, discrete, and complex business, to meet the needs of the Companys ongoing future strategy;
- Further enhancement of the Companys good reputation with all relevant stakeholders and sectors;
- Reduction in regulatory obstacles through application of new technologies and an effective and motivated workforce;
- Improvement of current levels of grant and other income;
- Delivery of the strategic direction, and business objectives, of the Company;
- Taking full responsibility of Quality Systems (including GxP).
- Communication and key working relationships
- Scientific and management of colleagues throughout company.
- National and international scientific experts, academic institutions, private and public sector customers.
MAIN DUTIES AND RESPONSIBILITIES
- Lead the QMS & Compliance teams to deliver compliant Quality systems, and develop a world-class QMS;
- Provide operational direction and leadership to a large team of GMP Quality professionals, Documentation control, & Archivist staff;
- Develop and manage the QA, GMP, & QMS programmes, policies, standards, and procedures to ensure conformance to the highest standards and regulatory agency requirements (MHRA, EU, FDA etc.);
- Establish processes and systems that support collaboration, compliance and are simple and effective;
- Lead and support where required with regulatory inspections;
- Further develop, implement and manage processes that align with, and drive, effective systems for change control, deviations and investigations, complaints, recalls, risk management and CAPA;
- Oversee GMP Quality system performance metrics, analyse compliance data and coordinate the necessary Quality reporting and escalation responses;
- Manage the processes for the Quality Management Review Board, Change Control Review Board and Risk Management forums;
- Provide expertise and guidance to senior management in the interpretation of global GMP regulations, ICH guidelines and internal policies and procedures;
- Promote continuous improvements in quality systems and department infrastructure; assist with creation/revision of appropriate SOPs, Code of Practices, Policies & Key Quality documents;
- Train, manage, and mentor QMS, GMP, & QA staff for the effective performance in cGMP processes & compliance activities.