Compliance Manager

8 hours ago

Sydney, New South Wales, Australia Discover International Full time $80,000 - $120,000 per year

About the Company

Our client is a leading pharmaceutical manufacturer dedicated to delivering high-quality medicines that improve patient lives. With a strong focus on operational excellence, regulatory compliance, and continuous improvement, they are expanding their Quality organisation and seeking a GMP Compliance Manage
r
to strengthen site compliance and inspection readiness.

The Role

As GMP Compliance Manager, you will play a key role in ensuring that all manufacturing, testing, and quality operations are conducted in full compliance with global regulatory standards (EU GMP, FDA, ICH). You will lead compliance activities, support internal and external inspections, and drive a culture of quality and accountability across the organisation.

Key Responsibilities

  • Act as the site lead for GMP compliance, ensuring adherence to applicable regulatory and company standards.
  • Manage and oversee self-inspection and internal audit programmes, ensuring timely closure of observations and CAPAs.
  • Support and host regulatory inspections and client audits, ensuring full readiness and professional representation of site operations.
  • Monitor, assess, and implement changes in regulatory requirements and industry guidelines.
  • Partner with cross-functional teams (QA, QC, Production, Engineering) to proactively identify and mitigate compliance risks.
  • Lead GMP training initiatives and promote a strong compliance culture throughout the organisation.
  • Prepare and review key compliance metrics and quality reports for senior management.

Qualifications & Experience

  • Degree in Pharmacy, Life Sciences, or a related scientific discipline.
  • Minimum 5 years of experience in a GMP-regulated pharmaceutical or biopharmaceutical environment.
  • Strong understanding of GMP, FDA principles.
  • Demonstrated experience in managing audits, inspections, and compliance programmes.
  • Excellent communication and stakeholder management skills.
  • Fluent in English; additional languages are an advantage.

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