Quality Manager

Role Relationships Reporting: the post-holder will report directly to the CORRIB and CRF Directors, working closely with the Clinical Trials Programme Manager and Clinical Operations Lead. The post holder will have specific daily contact with: • Senior Members of CORRIB-CRF Research Centre and HRB-CRFG (Clinical Trials Programme Manager, Clinical Research Operations Lead, Biometrics Unit Lead Quality Managers at HRB-CRFG • Director(s) of CORRIB Research Centre and HRB-CRFG • Validation Officer at CORRIB Research Centre and HRB-CRFG • Statisticians at HRB-CRFG and CORRIB Research Centre & Core Lab • CORRIB Research Centre and HRB-CRFG Trial Coordination team members (e.g. senior trial coordinators/project managers, data management/development team, IT officer etc.) • HRB-CRFG clinical trials site teams • CORRIB-CRF Research Centre & Core Lab Academic Team, students (post graduate) and research fellows / CRF • Clinical Research and Development Office (CRDO) • Professional Services staff at University of Galway and/or Saolta Health Care Group

The post holder has general contact with: • Director of Strategic Development, College of Medicine, Nursing and Health Sciences • Director of Risk and Internal Audit, University of Galway • HR and Finance Business Partners, College of Medicine, Nursing and Health Sciences • Other University Offices including but not limited to the Office of the Registrar and Deputy President, Buildings Office, Research Office, Research Accounts, Procurement, Information Systems and Solutions, Human Resources, International Affairs. Main Purpose of Job The purpose of this role is to lead the quality assurance processes required to verify that the rights and well-being of trial participants are protected, and that the integrity of the trial data is upheld. The role will be working within a highly qualified team to ensure quality assurance and compliance in the running of Clinical Research Trials in the CORRIB Research Centre for Advanced Imaging and Core laboratory and Clinical Research Facility (CRF). They will provide Quality Assurance expertise to the CORRIB Research Centre for Advanced Imaging and Core laboratory and the Clinical Research facility. This achieved by maintaining the following key processes/areas: Quality system processes, Regulatory compliance, Document Control, Training, CAPA management, vendor qualifications and Computer System Validation Processes for the unit. The post-holder will report directly to the CORRIB / CRF Directors, working closely with the Clinical Trials Programme Manager and Clinical Operations Lead. CORRIB--CRF Unit Directors CORRIB-CRF Quality Manager Trial Co-ordination Team Research Fellows / Analysts Programme ManagerOperations Lead 4. Main Duties and Responsibilities • Provide Quality Assurance expertise to the CORRIB Research Centre for Advanced Imaging and Core laboratory and Clinical Research Facility to support the quality assurance of clinical research in CORRIB and CRF. • Maintain the following key processes/areas as they apply to the CORRIB and CRF Research Centres: Quality system processes, Regulatory compliance, Document Control, Training, CAPA management; Clinical Study Greenlight Process; study implementation, study close down and study archiving. • Lead contact for vendor qualifications and audits of CORRIB-CRF by external sponsors and inspections by regulatory authorities, in accordance with local procedure and in adherence with institutional requirements. • Support operations team in vendor management processes for CORRIB- CRF vendors and service providers including risk assessment and vendor audit if required. • Work under the Clinical Research QMS process and with support from the Head of Clinical Research Quality and Regulatory Affairs to interpret complex legislation relating to clinical research, identify the implications for CORRIB-CRF and act to initiate necessary changes to practice in order to ensure that the CORRIB-CRF remains compliant with statutory regulations. • Undertake gap analyses of CORRIB-CRF processes against complex regulatory and legal requirements and implement measures to mitigate risk to the CORRIB-CRF and University of Galway and Sponsors. • Maintain quality system processes in collaboration with the CRDO, to ensure that studies carried out in the CORRIB-CRF are conducted in accordance with Good Clinical Practice (GCP) standards, national and international legislation and meet the quality needs of the CORRIB-CRF personnel. • Establish and implement quality monitoring systems, complimenting existing processes, to ensure regulatory compliance throughout the lifecycle of CORRIB-CRF studies including those for which University of Galway is legal Sponsor. • Develop QA procedures to support study initiation, study implementation, study close down and study archiving. • Review any regulatory or Sponsor inspection findings, taking responsibility for coordinating remedial action. • Manage the document control system and provide oversight for the standard operating procedures process, coordinating approvals and ensuring it is maintained, current and compliant, implementing corrective actions for any gaps identified. • Control and supervise regulatory compliance for CORRIB-CRF line managers, from a quality perspective. • Adherence to the requirements of GCP, ISO14155 and all associated regulatory, ethical and legislative requirements in the execution of the work carried out in CORRIB Core Lab and CRF. • Coordinate and deliver mandatory training for CORRIB-CRF staff, including CSV training as required, ensuring that staff records are complete and compliant with the principles of GCP. • Contribute to the maintenance of the existing Corrective Action Preventative Action (CAPA) processes and non-conformance system and implement continuous improvement to associated processes as required. • Maintain and participate in the internal audit system and perform quality assurance review of the CORRIB-CRF as needed, in order to check that facilities, services and staff are prepared for regulatory inspection and that individual staff members are aware of their research governance responsibilities. • Support existing risk management processes and undertake risk assessments of novel processes and studies as required to mitigate risk to the CORRIB-CRF and University of Galway and Sponsors • Ensure required compliance, governance and oversight is maintained locally within CORRIB-CRF • Support all validation activity as it applies to the processes, software, electronic systems and equipment in CORRIB-CRF. • Support Computer system validation expertise and support clinical research associated validation activity (e.g. EDC software, randomisation software, Electronic document management systems, study management software, Cardiology analysis software systems, imaging transfer systems). • Support the CSV change control process and controlled software installation and updates relating to clinical research in CORRIB-CRF. • Lead regulatory inspections and internal audits. • Undertake additional team tasks as agreed to support effective running of the CORRIB-CRF Research Centre for Advanced Imaging and Core laboratory. • Any other duties that arise during the ambit of the post. Requirements for the role: The successful candidate will demonstrate the eligibility requirements below in terms of qualification, skills and experience:

Essential Criteria • Bachelor's degree in a scientific, engineering or health care field, or equivalent experience • Minimum of 5 years' experience of working within an industry based (e.g. medtech, biomedical, pharmaceutical industry) regulated quality management system in a similar or related role(s) working under a quality system framework • Experience in developing quality strategies and quality assurance processes. • Knowledge and proven application of established risk management processes. • The role requires a candidate who can lead and work autonomously on process development and implementation and management and also someone who is a strong team player. • Experience in the delivery of training. • Excellent oral and written communication skills. • Excellent organizational and interpersonal skills.

Desirable Criteria • Postgraduate qualification in clinical or life science related subject • Experience working in quality assurance, risk management, audit and/or regulatory inspection. • Project Management skills. • Knowledge of clinical research practices . • ICH-GCP and/or ISO14155 Training.

The above criteria will be utilised to shortlist and select candidates for interview. Salary: €59,826 - €81,106 per year

CLICK THE APPLY BUTTON TO GO TO THEIR CAREERS PAGE WHERE YOU CAN CHECK THIS JOB AND ALL OTHER OPPORTUNITIES AVAILABLE.