GMP Training & Compliance Manager

Frenchs Forest, NSW | Full-time | 9-5 (Hours May Vary)
Salary: $100,000 - $105,000 + Super

Join a growing biotechnology manufacturing organisation and lead the design and governance of GMP training and competency systems that support operational excellence and regulatory compliance.

We are seeking an experienced GMP Training & Compliance Manager to own the end-to-end training framework within a highly regulated manufacturing environment.

About the Role

You will lead the organisation's training and competency strategy, ensuring all manufacturing staff are qualified, assessed, and audit-ready at all times. This role works across Quality, Operations, and Workforce Capability to drive compliance and continuous improvement.

Key Responsibilities

• Design and maintain GMP competency frameworks and structured training pathways
• Manage the Training Management System (TMS) and maintain audit readiness
• Lead competency assessments, gap analysis, and retraining initiatives
• Oversee training compliance relating to deviations, CAPAs, and audit outcomes
• Coordinate training for new product introductions and manufacturing system changes (MES, LIMS, EBR)
• Support system upgrades, UAT activities, and go-live training requirements
• Ensure SOP and process changes are effectively trained and implemented
• Lead and develop direct reports within the training function
• Act as the key training contact during TGA, ISO 13485, and FDA audits

About You

• 7+ years' experience in GMP training, quality, competency, or regulated manufacturing environments
• Strong experience designing and managing competency-based training systems
• Working knowledge of GMP, ISO 13485, and TGA requirements
• Experience leading training workstreams for system implementations or upgrades
• Strong stakeholder engagement skills across operational and leadership teams
• Certificate IV in Training and Assessment and/or tertiary qualification desirable

Additional Requirements

• Monday to Friday, 9-5 (hours may vary)
• Car licence required

What's on Offer

• Senior leadership opportunity within a growing biotechnology manufacturing environment
• Direct impact on compliance, workforce capability, and operational performance
• Exposure to advanced manufacturing systems and regulatory frameworks
• Opportunity to shape and enhance training strategy across GMP operations

At HOBAN we encourage applications from people with disability, people from diverse cultural and linguistic backgrounds, people of all genders, LGBTI people, and Aboriginal and Torres Strait Islander people.

We provide reasonable adjustments; including alternate formats to the recruitment process for individuals with disability. If you require an adjustment to be made during the recruitment process, please email our Adjustments Coordinator at adjustments@hoban.com.au or visit hoban.com.au/adjustments for additional contact details.