Global Compliance Auditor

3 days ago

Brisbane, Queensland, Australia beBeeCompliance Full time US$214,100 - US$264,500
Job Description

Ultragenyx is seeking a Director, Global Compliance Audit, to lead the external audit program, internal self-inspection program, and support the audit lifecycle for vendors and suppliers.

The ideal candidate has experience in Quality or Operations (Manufacturing and/or QC) with GxP Compliance Auditing of pharmaceutical manufacture/testing/distribution. They must be able to identify and develop procedures and process improvements, analyze Corrective Action/Preventative Action plans, and communicate assessments of compliance and inspection risks to support business-critical decisions.

The role requires strong working knowledge and interpretation of FDA, EMA, MHRA, ICH, and other global regulations and guidelines. The candidate must also have experience with GxP auditing practices and methodology, as well as familiarity with all phases of biologic/gene therapy/mRNA drug development.

Responsibilities
  • Lead and participate in GxP compliance audits, authoring, reviewing, and approving audit reports.
  • Assess the effectiveness of corrective actions in response to internal and external audits, negotiating improved CAPA plans with stakeholders.
  • Provide compliance oversight to ensure product quality during operations and adherence to applicable global Health Authority regulations, requirements, and expectations.
  • Determine and inform Executive Leadership when potential Quality and/or regulatory issues at CMOs may impact product quality, patient safety, supply chain, and/or regulatory compliance.
  • Develop, review, and approve department-specific SOPs and corporate standards in support of the Quality Management System.
  • Communicate department metrics and monitor performance.
  • Serve as a Compliance representative on cross-functional and multi-site teams, providing compliance interpretation of GxP to clinical and commercial operations.
  • Lead and partner with external contract organizations and internal stakeholder departments to drive continuous improvement of audit processes, procedures, and product quality.
Requirements
  • 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.
  • Familiarity with all phases of biologic/gene therapy/mRNA drug development.
  • Demonstrates high personal and professional ethical standards.
  • Experience with computerized systems and compliance requirements.
  • Broad and direct experience with regulatory authority inspections, including both FDA and EMA inspections, is a plus.
  • Experience working with contract manufacturing, laboratory, and distribution organizations is a plus.
  • Strong organizational and project management skills with a track record of meeting goals/objectives.

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