Global Compliance Audit Director

3 days ago

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

We are seeking an experienced professional to lead and execute our external audit program, internal self-inspection program, and support the audit lifecycle for vendors and suppliers. The ideal candidate will have experience as a Quality or Operations (Manufacturing and/or QC) professional, GxP Compliance Auditing of pharmaceutical manufacture/testing/distribution, identifying and developing procedures and process improvements, analyzing Corrective Action/Preventative Action plans.

About This Role
  • Lead and participate in GxP compliance audits. Author, review and approve audit reports
  • Assess the effectiveness of corrective actions in response to internal and external audits and negotiate improved CAPA plans with audit stakeholders
  • Provide compliance oversight to ensure product quality during operations and adherence to applicable global Health Authority regulations, requirements and expectations

This role will require strong organizational and project management skills with a track record of meeting goals/objectives. Flexibility to accommodate program priorities and international activities is necessary. Up to 50% travel may be required.

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
What We Offer

Ultragenyx Pharmaceutical is an equal opportunity employer. This position is eligible for annual bonus and equity incentives. Reasonable accommodation will be provided for all protected statuses or classifications.

Voluntary Self-Identification Survey

We invite you to voluntarily provide demographic information in a confidential survey at the end of this application.

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