Quality & Regulatory Affairs Group Manager

i-Pharm Consulting; Brisbane; On-site; AUD 150,000 - 190,000; Full time

Job summary

i‑Pharm Consulting is seeking a Quality & Regulatory Affairs Group Manager in Brisbane to lead the Pharmaceutical Quality System, regulatory affairs and compliance across sites. The role reports to the Executive General Manager and drives quality strategy, risk management and inspection readiness.

The role requires senior leadership experience in medicinal cannabis or regulated manufacturing, with direct regulatory exposure to ODC and TGA, and deep knowledge of GMP/PIC/S standards.

Qualifications

• 7+ years in medicinal cannabis/pharma with senior leadership.
• Experience in QA, GMP, regulatory affairs and Validation Master Planning.
• Direct regulatory experience with the Office of Drug Control (ODC).
• TGA quality experience including exports.
• Experience leading a quality team and managing managers.
• Knowledge of TGA, ODC and PIC/S requirements.
• Ability to make difficult business decisions under pressure.

Responsibilities

• Own the Pharmaceutical Quality System including change control, investigations, CAPA, complaints and recalls.
• Lead regulatory inspections and external audits with GMP/GACP readiness.
• Own the Validation Master Plan and supplier/outsourced-activity quality program.
• Lead registrations, licensing and submissions; liaise with TGA and ODC.
• Oversee quality compliance for domestic and export activities.
• Present risks with recommendations to Executive team; quantify outcomes.
• Build and resource the Quality & Regulatory Affairs team; leadership reporting.
• Align quality recommendations with Executive decisions.

Skills

Quality Assurance

Regulatory Affairs

GMP Principles

Leadership

TGA/ODC knowledge

Risk & Compliance

Education

Bachelor degree in Science, Pharmacy, or related discipline

Job description

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