Quality & Regulatory Compliance Team Lead

|Scientific & Pharmaceutical - Quality Assurance & Regulatory|Auckland
  • Make a positive impact by working with critical healthcare products
  • Learn and grow under the guidance of an experienced and supportive manager
  • Thrive in a fast-paced role where your hands-on contributions are essential

 
The Company: Our client is a New Zealand–owned and operated pharmaceutical manufacturer with over 25 years of experience producing high-quality intravenous, aseptic, and non-sterile products. Known for their fast-paced operations, they often process, manufacture, and deliver products on the same day. The team has a strong commitment to continuous learning and development, and this business fosters an environment where employees are supported to expand their skills across different areas.

If you’re seeking work that is both impactful and growth-oriented, this is an excellent opportunity.

 
The Role: Our client is seeking a hands-on Quality & Regulatory Compliance Team Lead to support their highly motivated QRC team. This is an onsite role, at their conveniently located central Auckland facilities. The role is critical to ensuring compliance with GMP, GLP and regulatory standards, whilst also overseeing operational excellence and product quality.

Key responsibilities will include, but are not limited to:

  • Leading the review of documentation for finished products and making timely release decisions
  • Overseeing batch document reviews for aseptic department products
  • Managing reject systems: raising notes, maintaining logs, and ensuring SOP compliance
  • Handling customer complaints and conducting investigations
  • Performing and delegating internal audits, preparing reports, and implementing corrective actions
  • Managing the change control process
  • Leading deviation and quality investigations, identifying root causes, and initiating corrective actions
  • Commissioning and decommissioning production equipment
  • Authorising master documents, regulatory quality documents, and SOPs
  • Reviewing and authorising validations of equipment, processes, and facilities
  • Preparing trend reports on deviations, sterility testing, and environmental result

 
Working hours:

  • Tuesday – Friday: 12.00pm – 8.30pm
  • Saturday: 9.00am – 5.30pm

 

You, the Candidate: The ideal candidate for this role will bring strong knowledge of GMP and regulatory systems, have a substantial background in pharmaceutical / sterile manufacturing and excellent attention to detail. Leadership experience is advantageous but not essential, with a supportive and growth focused manager there to support you.

You will also bring the following skills and attributes:

  • A degree in chemistry, microbiology or related scientific discipline is essential.
  • Excellent knowledge of GMP
  • A minimum of 5 years demonstrated experience in a quality/compliance related role within a pharmaceutical or sterile manufacturing.
  • A proactive and resourceful approach to learning and research
  • Strong communication skills and ability to communicate cross-functionally
  • Proven analytical and problem-solving skills

 

How to Apply: To apply for this role, please select the relevant ‘Apply’ button. Alternatively, please contact Maya Carpenter-Salvador on maya@trs.co.nz with a copy of your CV.

We look forward to hearing from you!