Senior Manager, Clinical QA

4 weeks ago

Brisbane, Queensland, Australia Tbwa ChiatDay Inc Full time
Job Title: Senior Manager, Clinical QA & GxP Compliance

At Ultragenyx Pharmaceutical, we are seeking a highly skilled and experienced Senior Manager, Clinical QA & GxP Compliance to join our team. As a key member of our Clinical Quality Assurance department, you will be responsible for ensuring the quality and integrity of our clinical trials and compliance with regulatory requirements.

Key Responsibilities:
  • Provide oversight of GCP activities, including ensuring patient safety, data integrity, and compliance with SOPs, GCP, and applicable regulations.
  • Execute the GCP Audit Plan and support Inspection Management goals and objectives.
  • Train, coach, and oversee Clinical QA personnel, subject matter experts, and contract service providers in preparing, conducting, and reporting GxP audits.
  • Support inspection readiness activities, associated Health Authority Inspections, and perform assigned War Room leadership role.
  • Review GCP-associated controlled documents, including SOPs, protocols, and study-specific documents, in accordance with applicable regulatory requirements.
  • Provide guidance and support to internal departments and Clinical Study teams in the identification and investigation of potential GCP and compliance issues.
Requirements:
  • Bachelor's Degree in a scientific or related technical discipline.
  • At least 7+ years' experience in Biotech/Pharmaceutical industry, Quality Assurance experience preferred.
  • Strong working knowledge and interpretation of global GCPs, particularly U.S. FDA/EU and ICH regulations and guidelines.
  • Excellent communications skills, both written and verbal.
  • Flexible in the face of shifting needs and/or priorities.
  • Motivated, committed, and self-managed.

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