Quality Compliance Senior Manager - Labelling & Regulatory Affairs

Amgen

Cambridge, United Kingdom
**
Quality management system (qms)
Safety & medical quality (smq)
Pharmacovigilance (gpvp) audit plan
** Amgen is seeking a Quality Compliance Senior Manager for Labelling & Regulatory Affairs to enhance its R&D Quality Management System. The role involves overseeing compliance processes related to pharmacovigilance and regulatory affairs, ensuring adherence to quality standards and regulations. **

Job Summary

  • This role will lead Safety and Medical Quality processes with a focus on labelling and regulatory affairs activities.
  • You will join a globally established team and your role will encompass decision-making authority for Labelling and Regulatory Affairs.
  • Amgen offers vast opportunities to learn and move up and across our global organization, a diverse and inclusive community, and a generous Total Rewards Plan.

Matching Summary

Match Score: 75

** Amgen is seeking a Quality Compliance Senior Manager for Labelling & Regulatory Affairs to enhance its R&D Quality Management System. The role involves overseeing compliance processes related to pharmacovigilance and regulatory affairs, ensuring adherence to quality standards and regulations. **

Skills & Requirements

Must-have

  • Quality Management System (QMS)
  • Safety & Medical Quality (SMQ)
  • pharmacovigilance (GPvP) audit plan
  • regulatory authority inspections
  • Root Cause Analysis (RCA)
  • Corrective and Preventive Action plans (CAPA)

Nice-to-have

  • innovative and proactive quality oversight methodologies
  • decision-making authority
  • diverse and inclusive community

Key Requirements

  • Degree educated
  • Experience in Quality Management
  • Thorough knowledge of R&D processes
  • Knowledge of Good Pharmacovigilance Practice (GPvP)
  • Experience supporting regulatory authority inspections
  • Experience leading process improvement initiatives

Work Rights

Not specified

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