Quality Compliance Manager

6 days ago

Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time

Job Opportunity:

This exciting role offers a unique blend of quality and regulatory affairs responsibilities, providing an exceptional opportunity for professional growth and development.

The successful candidate will be responsible for managing key quality systems, including change controls, deviations, complaints, and CAPAs, while supporting regulatory activities across a diverse product portfolio.

Working closely with cross-functional teams and external partners, you will play a central role in maintaining compliance and ensuring timely approvals and documentation.

Key Responsibilities:

  • Act as the liaison between customers and corporate quality functions
  • Manage change controls, deviations, complaints, and CAPAs
  • Support product quality reviews and GMP compliance activities
  • Prepare and submit regulatory variations and notifications to authorities
  • Provide guidance on labelling and regulatory documentation for submissions
  • Assist with packaging and artwork issue resolution
  • Coordinate cross-functional collaboration with R&D, Supply, and Business Development
  • Identify and support quality system improvements and handle technical queries

Requirements:

  • Tertiary qualification in Science, Pharmacy, or related discipline
  • 3-4 years of experience in pharmaceutical Quality Assurance or Regulatory Affairs
  • Strong understanding of GMP, TGA, and Medsafe regulatory frameworks
  • Exceptional attention to detail and organisational skills
  • Strong stakeholder communication and project coordination abilities
  • Self-motivated, adaptable, and proactive in driving process improvement

Benefits:

  • Ownership of both QA and RA activities with strong mentoring and support
  • Great opportunity for professional growth and cross-functional collaboration
  • Work with a global pharmaceutical company committed to continuous improvement
  • Hybrid working

Join our team that values open communication, innovation, and continuous learning. We encourage initiative and support career development through exposure to diverse projects and global best practices.

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