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Quality Manager

3 months ago

Auckland City, New Zealand PeopleHQ Full time

Our client, Pacific Clinical Research Network is a group of private research facilities, with sites located across New Zealand. This is an exciting opportunity for an experienced Quality Manager to join the national team.

**In this role you will**:

- Develop, implement and maintain a Quality Management System (QMS) and present as required to Pharma companies as part of contractual negotiations
- Develop and implement a risk-based adaptable approach to quality assurance (QA) to ensure trial participants and data are safeguarded in compliance with applicable regulatory requirements
- Train and mentor clinical staff to implement, review and maintain tracking of incidents with the clinical trials
- Advise on corrective and preventative actions to be implemented
- Regularly review all policies, SOP's and internal operating procedures
- Review and ensure compliance with ethical and regulatory requirements, and advise on improvement strategies
- Determine and facilitate training on SOP requirements relating to quality assurance and quality control
- Supervision of clinical staff conducting trials as required
- Lead preparation for audit processes from external parties
- Provide advice and guidance on trial master files, regularly auditing for compliance
- Develop an internal risk-based audit programme for systems and trials in collaboration with teams across all sites
- Provide QA advice and interpretation of GCP regulations
- Develop post-trial review practices for continual improvement purposes
- Maintain a sound working knowledge of the investigational product requirements for the clinical trials
- Lead strategic planning initiatives for QA requirements, sharing the vision with the wider leadership team
- Proven experience as an executive or equivalent relevant role
- 3-5 years experience within the healthcare sector in a same or similar role
- The ability to travel around New Zealand and overseas if required on occasion
- Expert knowledge of health and safety protocols
- Exceptional organisational skills and a high level of communication skills
- Proven ability to run audit processes
- Networking and stakeholder management skills
- Excellent administration and computing skills
- High attention to detail, maintaining excellent documentation practices
- Experience in a clinical research unit is desirable but not essential

**Why PCRN?**

Working as part of an expert team with competitive remuneration and an exciting place to work. PCRN is built on, and values working as a team. You’ll experience absolute professionalism, with a hint of humour and collaboration. This is an exciting new role, with a strong and supportive management team and a great reputation.

**RECRUITMENT INFORMATION**

Applications will be reviewed as received.