Quality & Regulatory Affairs Group Manager
An established Australian cultivator and manufacturer of plant-based medicines, with operations spanning medicinal cannabis research, development and international supply. The business is driven by a clear purpose to improve lives through natural medicine.
The team brings together commercial leaders, horticulturists, scientific researchers and medical advisors who share a commitment to product quality and patient outcomes.
About the business
An established Australian cultivator and manufacturer of plant-based medicines, with operations spanning medicinal cannabis research, development and international supply. The business is driven by a clear purpose to improve lives through natural medicine.
The team brings together commercial leaders, horticulturists, scientific researchers and medical advisors who share a commitment to product quality and patient outcomes.
About the role
Reporting to the Executive General Manager, the Quality & Regulatory Affairs Group Manager holds independent accountability for the organisation'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 across GMP and GACP
- Own the Validation Master Plan and the supplier and outsourced-activity quality program
- Lead registrations, licensing and submissions, and represent the organisation with the TGA and ODC
- Oversee quality compliance for domestic and export activities
- Present material quality and compliance risks to the Executive team, supported by clear recommendations, options and likely outcomes
- Lead, develop and resource the Quality and Regulatory Affairs team, including management-level reports
- Build stakeholder buy-in for quality and compliance recommendations while recognising that final business decisions sit with the Executive Leadership Team
About you
- Bachelor of Science (Chemistry or Agriculture), Pharmacy, or a related discipline
- 7+ years' experience within medicinal cannabis, pharmaceuticals or related regulated manufacturing, including senior leadership experience
- Demonstrated experience in Quality Assurance, GMP principles, Regulatory Affairs and Validation Master Planning
- Direct regulatory experience with the Office of Drug Control (ODC)
- Demonstrated TGA quality experience, including exports
- Experience leading a quality team and managing managers
- Current knowledge of TGA, ODC and PIC/S requirements
- Sound judgement and the credibility to hold a quality position under commercial pressure
- Senior leadership experience developing recommendations on difficult business decisions, including those unfavourable to stakeholders
Candidates must demonstrate experience across ODC regulation, TGA quality and exports, team and manager leadership, and senior business decision-making
Location: Brisbane, QLD
Quality & Regulatory Affairs Group Manager in Brisbane employer: i-Pharm Consulting
i-Pharm Consulting is an exceptional employer that values its employees by fostering a collaborative and innovative work culture. With a focus on professional development, you will have ample opportunities to grow your expertise in regulatory affairs while working remotely across Australia and New Zealand. The company offers competitive benefits and a supportive environment that encourages meaningful contributions to the healthcare sector.
