Position Purpose The purpose of this role is to lead and continuously improve NZCRs Quality Management System, ensuring it meets all regulatory requirements and industry standards. The Quality Manager champions a culture of quality, compliance, and continuous improvement, ensuring that research activities are conducted to the highest standards across all sites. This role provides strategic leadership to the Quality Team and works collaboratively across the organisation to embed quality in every aspect of NZCRs operations .

Responsibilities Quality Manager Development, maintenance, and improvement of quality management system processes, including the eQMS, ensuring ICH-GCP guidelines are maintained. Ensure that the Quality Team is consistently meeting the delivery of quality standards, and that this is aligned across all sites. Drive a culture of innovation and continuous improvement across the Quality Team and with all NZCR staff.

Oversee the management of the document management system, ensuring documents are reviewed and updated within applicable timeframes. Write and implement quality assurance policies and procedures. Provide leadership and guidance to Quality Team staff ensuring policies and procedures meet industry guidelines and standards, and NZCR document requirements.

Oversee the internal auditing programme to ensure studies and NZCR activities are conducted in accordance with sponsor protocols, ICH-GCP and other applicable guidelines and standards. Work with the senior management at the site to ensure that quality is at the forefront off all NZCR functions, and champion the implementation through all of NZCR processes and policies. Assist in the audits of vendors, ensuring their compliance with contractual obligations, trial protocol requirements and regulatory standards.

Review and manage the CAPA system, ensuring CAPAs are effectively implemented within agreed timeframes. Incident and complaints management via root cause analysis or other quality assurance incident analysis tools. Prepare reports and lead quality management reviews of the effectiveness of the quality management system.

Ensure the delivery of Quality related training programmes to ensure compliance and continuous improvement. Ensure on-going compliance with quality and clinical trial regulatory requirements. Manage all privacy and confidentiality regulatory requirements at the site.

Investigate and report privacy breaches, where applicable. Provide leadership of the Quality team across the site to ensure there is development of staff, building experience and knowledge of quality function and related outputs. Other quality assurance and quality control activities as required.

Quality Maintain compliance with all New Zealand Clinical Research standards, protocols, and regulatory requirements, adhering to Good Clinical Practice (GCP). Regularly evaluates, documents, and refines clinical and operational processes to enhance accuracy, consistency, and overall quality. Assi.