Quality & Regulatory Compliance Team Lead

OverviewQuality & Regulatory Compliance Team Lead at Technical Recruitment Solutions Ltd.

Onsite role in central Auckland.

Responsible for ensuring GMP, GLP and regulatory standards are met, while overseeing operational excellence and product quality within the QRC team.About the CompanyDedicate your quality & regulatory compliance expertise to a company whose products make a direct impact on the lives of New Zealanders.

A New Zealand–owned and operated pharmaceutical manufacturer with over 25 years of experience producing intravenous, aseptic, and non-sterile products.

Known for fast-paced operations and a strong commitment to continuous learning and development.ResponsibilitiesLeading the review of documentation for finished products and making timely release decisionsOverseeing batch document reviews for aseptic department productsManaging reject systems : raising notes, maintaining logs, and ensuring SOP complianceHandling customer complaints and conducting investigationsPerforming and delegating internal audits, preparing reports, and implementing corrective actionsManaging the change control processLeading deviation and quality investigations, identifying root causes, and initiating corrective actionsCommissioning and decommissioning production equipmentAuthorising master documents, regulatory quality documents, and SOPsReviewing and authorising validations of equipment, processes, and facilitiesPreparing trend reports on deviations, sterility testing, and environmental resultsWorking HoursTuesday - Friday : 12.00pm – 8.30pmSaturday : 9.00am – 5.30pmCandidate ProfileThe ideal candidate will have strong knowledge of GMP and regulatory systems, substantial experience in pharmaceutical / sterile manufacturing, and excellent attention to detail.

Leadership experience is advantageous but not essential, with a supportive and growth-focused manager.A degree in chemistry, microbiology or related scientific discipline is essential.Excellent knowledge of GMPA 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 researchStrong communication skills and ability to communicate cross-functionallyProven analytical and problem-solving skillsHow to ApplyTo apply for this role, please select the relevant 'Apply' button.

Alternatively, contact Maya Carpenter-Salvador at

• with a copy of your CV.We look forward to hearing from you!

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