Highly Regulated Pharmaceutical Operations Specialist

6 days ago

Melbourne, Victoria, Australia beBeeRegulatory Full time $100,000 - $130,000

Our organization seeks an experienced Regulatory Compliance and Training Specialist to ensure high standards of compliance, quality, and training across all operations in a highly regulated pharmaceutical environment.

Key Responsibilities:

  • Lead regulatory compliance with TGA, OGTR, DAFF, and ISO standards across all facilities operations.
  • Develop and deliver customized training programs for staff and subcontractors, including advanced therapies and GMO handling.
  • Oversee internal and external audits, including TGA GMP inspections and DAFF biosecurity reviews.
  • Drive continuous improvement using Lean, Six Sigma, and validation engineering principles.
  • Maintain Safe Work Procedures, subcontractor compliance (licences, insurances, SWMS), and contribute to Zero Harm initiatives.

Requirements:

  • Proven experience in the pharmaceutical, FMCG, or other highly regulated industries.
  • Proven experience in compliance auditing, training delivery, and stakeholder engagement.
  • Strong knowledge of regulatory frameworks including TGA, OGTR, DAFF, and ISO.
  • Experience leading cross-functional teams and managing contract KPIs.
  • Familiarity with Lean, Six Sigma, and continuous improvement methodologies.

About Our Organization:

We are a leading provider of essential public services across Australia and New Zealand, managing critical infrastructure that keeps communities thriving. Our commitment to diversity and high-performance culture offers opportunities for career advancement and professional growth.

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