Senior Quality & Regulatory Affairs 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

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.