21 Sep
|
Lead Group
|
Perth
About the Opportunity An established and growing Australian pharmaceutical manufacturing business is seeking an experienced General Manager – GMP Pharmaceutical Manufacturing to lead manufacturing operations across two Western Australian facilities.
The organisation operates across cultivation, post-harvest, extraction, formulation and pharmaceutical manufacturing, with significant infrastructure already established and further manufacturing capability being commissioned.
With commercial production underway, the business is entering its next stage of growth, focused on scaling pharmaceutical manufacturing, strengthening operational systems, increasing production capacity and preparing for further domestic and international supply.
This is a genuine senior leadership opportunity with substantial ownership of manufacturing performance and operational execution.
The Role
As General Manager – GMP Pharmaceutical Manufacturing, you will lead end-to-end manufacturing operations across the organisation's metropolitan Perth and regional WA facilities.
You will take ownership of production output, throughput, yield, capacity, cost, equipment, infrastructure, people and operational readiness.
Working alongside a dedicated senior Compliance and Quality leader, you will ensure manufacturing and quality functions remain closely aligned across GMP compliance, validation, inspections, batch release and regulatory requirements.
A major component of the position will be establishing and scaling newly developed pharmaceutical manufacturing capability while ensuring existing operations continue to perform effectively.
Key Responsibilities
- Lead day-to-day GMP pharmaceutical manufacturing across two WA facilities.
- Oversee extraction, purification, formulation, filling, packaging and labelling operations.
- Manage production of medicinal cannabis products including dried flower, oils, extracts and other finished dosage forms.
- Lead commissioning and qualification of new manufacturing equipment and facilities.
- Establish manufacturing procedures, workflows and operational systems.
- Manage production planning, capacity utilisation, throughput and scheduling.
- Drive improvements in manufacturing yield, efficiency and cost of goods.
- Maintain consistent manufacturing standards across multiple sites.
- Ensure manufacturing operations remain inspection and audit ready.
- Work closely with Quality and Compliance leadership across deviations, CAPA, change control, validation and batch release.
- Support compliance with PIC/S GMP, TGA requirements and relevant controlled-substance regulations.
- Support EU GMP readiness and international export requirements.
- Manage the manufacturing interface with cultivation and post-harvest operations.
- Oversee GMP-critical equipment, HVAC, water systems, extraction and formulation equipment, packing lines and warehouse infrastructure.
- Build and lead production, engineering, warehouse and operational teams.
- Establish KPIs, training programs and explicit operational accountability.
- Support capital expenditure, automation and manufacturing expansion projects.
- Support B2B manufacturing relationships, client audits, quality agreements and international supply requirements.
Essential Experience The successful candidate will ideally bring:
- Senior leadership experience within GMP pharmaceutical manufacturing
- Strong practical knowledge of PIC/S GMP and pharmaceutical quality systems.
- Experience within TGA-regulated manufacturing environments.
- Hands-on exposure to manufacturing processes such as extraction, formulation, filling, packaging and/or analytical operations.
- Demonstrated experience preparing manufacturing operations for regulatory inspections and maintaining audit readiness.
- Experience commissioning, establishing or scaling a GMP manufacturing facility.
- Experience managing complex or multi-site manufacturing operations.
- Strong understanding of production planning, capacity, yield, cost and operational performance.
- Proven experience building and leading multidisciplinary manufacturing teams.
- Strong commercial and operational judgement.
- Ability to operate effectively within a growing and evolving organisation.
- Willingness to be based in Perth with regular travel to a regional WA manufacturing facility.
Remuneration: Competitive senior leadership package, dependent on experience.
Location: Perth, Western Australia, with regular regional travel.
📌 General Manager – GMP Manufacturing (Perth)
🏢 Lead Group
📍 Perth