Quality Manager - Christchurch

New Zealand Clinical Research; Christchurch; On-site; NZD 80,000 - 100,000; Full time

Job summary

A leading clinical research organization seeks a Quality Manager to enhance its Quality Management System. This role involves ensuring compliance with regulatory standards, leading a dedicated team, and driving quality initiatives across the organization. The ideal candidate will have extensive experience in quality roles, particularly in the health or research sectors, and will champion a culture of quality and continuous improvement.

Qualifications

• 6-8 years’ experience in a quality role.
• Experience in Research/Health/Medical industry.

Responsibilities

• Lead and improve Quality Management System.
• Oversee internal auditing programme.
• Drive a culture of innovation and continuous improvement.

Skills

Leadership

Communication

Problem Solving

Attention to Detail

Education

Formal Quality Training

Tools

Q-Pulse

Microsoft Office

Job description

Position Purpose

The purpose of this role is to lead and continuously improve NZCR’s 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 NZCR’s 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.
• Assists in training employees in quality standards, policies, and procedures, ensuring all team members understand and implement best practices.
• Ensures accuracy, consistency, and currency in all research documentation and reporting, including accurate record-keeping, version control and timely updates.

Workplace Health and Safety

• Champions a culture of health and safety, ensuring preventative measures are in place to minimize risk to team members and participants.
• Actively identify and report health and safety hazards, accidents, incidents, injuries, and property damage.
• Understands and complies with NZCR’s Health and Safety policies and procedures.
• Maintains adherence to all safety standards and processes.
• Commits to personal health and safety at work.
• General
• Undertaking any other appropriate duties that may be required.

Minimum Position Qualifications

Education

• Minimum of formal quality training e.g. auditing.

Experience

• 6-8 years’ experience in a quality role
• Previous experience in a Research/Health/Medical industry.
• Previous experience working with Q-Pulse electronic management software preferred.
• Experience and good working knowledge of ISO9001 (2015)
• Experience in conducting root cause analysis investigations.
• Experience in conducting UAT validations of computer software system.

Knowledge, Skills & Experience

Essential

• Understanding of the necessity of having quality at the core of all organisational functions.
• Excellent people management and leadership skills, as demonstrated by a previous leadership role.
• Ability to communicate constructively and effectively, both orally and in writing with colleagues and external parties at a variety of levels.
• Ability to explain ideas in a way that is understandable and motivational for their team.
• Knowledge of research methodology and data management.
• Good knowledge of the national and international Regulatory and ethics principles, and procedures governing clinical research including ICH-GCP, FDA & MHRA requirements.
• Excellent working knowledge of the Privacy Act 2020.
• Respect the Confidentiality inherent in the role.
• A strong work ethic. Reliability, enthusiasm, and a positive attitude.
• Exceptional attention to detail.
• Ability to gather information/data, compile information, prepare reports, and meet timelines.
• A logical and organised approach to problem solving, and ability to put information in context/perspective.
• Skilled in the use of Microsoft office applications e.g. Word, Excel, and Outlook.