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Quality Manager

4 months ago

Manukau, Auckland, 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 riskbased 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 riskbased audit programme for systems and trials in collaboration with teams across all sites
  • Provide QA advice and interpretation of GCP regulations
  • Develop posttrial 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
  • 35 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.