Compliance Audit Lead

19 hours ago


Perth, Western Australia beBeeAudit Full time US$214,100 - US$264,500
Job Description

We are seeking a Compliance Audit Lead to execute the external audit program, internal self-inspection program and support the audit lifecycle for vendors and suppliers.

The candidate will communicate assessments of compliance and inspection risks to support business critical decisions that may impact Quality and Regulatory timelines and decisions.

Required Skills and Qualifications
  • Bachelor's Degree in Biological Science, Chemistry or related technical discipline
  • 10+ years' experience in Biotech/Pharmaceutical industry
  • Strong working knowledge and interpretation of FDA, EMA, MHRA, ICH and other global regulations and guidelines
  • Experience with GxP auditing practices and methodology
  • Familiar with all phases of biologic/gene therapy/mRNA drug development
  • Demonstrates high personal and professional ethical standards
  • Experience with computerized systems and compliance requirements
Benefits

Full-time employees enjoy a range of benefits, including generous vacation time and public holidays, volunteer days, long term incentive and Employee stock purchase plans, employee wellbeing benefits, fitness reimbursement, tuition sponsoring, and professional development plans.

About Our Team

We are a collaborative ecosystem that emphasizes a supportive and inclusive environment that promotes learning and growth.


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