Quality Compliance Senior Manager - Labelling & Regulatory Affairs

Amgen Inc

Cambridge, US
Quality management experience in pharmaceutical industry
Thorough knowledge of good pharmacovigilance practice
Experience supporting regulatory authority inspections
This role strengthens Amgen's R&D Quality Management System with a focus on labelling and regulatory affairs activities

Job Summary

  • This role strengthens Amgen's R&D Quality Management System with a focus on labelling and regulatory affairs activities.
  • The successful candidate will lead pharmacovigilance audit plans, manage compliance investigations, and support external regulatory inspections.
  • Amgen offers vast opportunities to learn and move up across its global organization within a diverse and inclusive community.

Matching Summary

This role strengthens Amgen's R&D Quality Management System 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
  • Root Cause Analysis and CAPA expertise
  • Risk assessment and management capabilities

Nice-to-have

  • Leadership or mentoring experience preferred
  • Process improvement initiative leadership
  • Proactive quality oversight methodologies
  • Global team collaboration skills

Key Requirements

  • Degree educated
  • Experience in Quality Management or Compliance
  • Knowledge of international GPvP requirements
  • Pharmaceutical/biotech industry background

Work Rights

Not specified

Tailored Resume

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