Quality Compliance Senior Manager - Labelling & Regulatory Affairs

Amgen Australia Pty Ltd

Cambridge, Victoria, Australia
Quality management experience in pharmaceutical industry
Thorough knowledge of good pharmacovigilance practice
Experience supporting regulatory authority inspections
This role will strengthen Amgen's R&D Quality Management System and lead Safety and Medical Quality processes with a focus on labelling and regulatory affairs activities

Job Summary

  • This role will strengthen Amgen's R&D Quality Management System and lead Safety and Medical Quality processes with a focus on labelling and regulatory affairs activities.
  • The successful candidate must possess thorough knowledge of international requirements of Good Pharmacovigilance Practice and Regulatory Affairs within the pharmaceutical industry.
  • Amgen offers vast opportunities to learn and move up across its global organization within a diverse and inclusive community of belonging.

Matching Summary

This role will strengthen Amgen's R&D Quality Management System and lead Safety and Medical Quality processes with a focus on labelling and regulatory affairs activities.

Skills & Requirements

Must-have

  • Quality Management experience in pharmaceutical industry
  • Thorough knowledge of Good Pharmacovigilance Practice
  • Experience supporting regulatory authority inspections
  • Leading process improvement initiatives
  • Root Cause Analysis and CAPA expertise

Nice-to-have

  • Previous leadership or mentoring experience
  • Proactive identification of compliance issues
  • Innovative quality oversight methodologies

Key Requirements

  • Degree educated
  • Experience in Quality Management or Compliance
  • Pharmaceutical/biotech industry background
  • Knowledge of GPvP & Regulatory Affairs

Work Rights

Not specified

Tailored Resume

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