Quality & Regulatory Affairs Group Manager

Australian Natural Therapeutics Group - Brisbane QLD

About the business

Australian Natural Therapeutics Group (ANTG) is an internationally recognised cultivator and manufacturer of advanced, plant-based medicines. As Australia's largest exporter and a pioneer in medical cannabis research and development, we're driven by one goal - to improve lives through the power of natural medicine.

Our team is made up of skilled commercial leaders, passionate horticulturists, scientific researchers, and medical advisors who live our values every day. Together, we're reimagining wellness and we'd love for you to be part of it.

About the role

Reporting to the Executive General Manager, the Quality & Regulatory Affairs Group Manager holds independent accountability for ANTG's Pharmaceutical Quality System, quality operations, regulatory affairs and compliance functions across all sites and outsourced activities. The role establishes the strategic direction of the Quality Management System, maintains oversight of product quality and patient safety, communicates material quality and compliance risks to the Executive team, and develops the capability and resources of the Quality and Regulatory Affairs function.

Responsibilities

Own the Pharmaceutical Quality System, including change control, investigations, CAPA, complaints and recalls





Lead regulatory inspections and external audits, and maintain inspection readiness (GMP and GACP)

Own the Validation Master Plan and the supplier and outsourced-activity quality program

Lead registrations, licensing and submissions, and represent ANTG with the TGA and ODC

Report material quality and compliance risks to the Executive team

Lead, develop and resource the Quality and Regulatory Affairs team

About you

Bachelor of Science (Chemistry or Agriculture), Pharmacy, or related discipline (minimum)

7+ years' experience within the medicinal cannabis, pharmaceutical, or related regulated manufacturing industry, including demonstrated senior/leadership level experience

Demonstrated experience in Quality Assurance (GMP Principles), Regulatory Affairs, and Validation Master Planning

Current knowledge of TGA, ODC and PIC/S requirements

Sound judgement and the credibility to hold a quality position under commercial pressure

Please note the role will be based in Brisbane with travel as required to Armidale, NSW.

Our commitment to Diversity & Inclusion:

We are an inclusive company, and our ambition is to attract, recruit and promote diverse talent.

Please note: All shortlisted candidates will be required to complete background checks including Medical (Drug & Alcohol), Bankruptcy, and Police Checks.

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📌 Quality & Regulatory Affairs Group Manager (Brisbane City)
🏢 Australian Natural Therapeutics Group
📍 Brisbane City