Quality Assurance Manager

4 weeks ago


Uxbridge, United Kingdom Amgen SA Full time
Job Description

As a Quality Assurance Manager at Amgen SA, you will play a vital role in ensuring the safety and quality of our observational research studies. Your primary responsibility will be to plan, conduct, and report on risk-based R&D audits, while supporting the completion of the audit plan for GPvP suppliers/vendors and processes.

Key Responsibilities:
  • Audit Planning and Execution: Plan, conduct, and report on risk-based R&D audits, ensuring compliance with global regulatory requirements for GPvP/GCP/observational research.
  • Safety and Quality Oversight: Investigate Quality events, including root cause analysis, design, development or Corrective and Preventive Actions (CAPAs) and Effectiveness Verifications (EVs).
  • Quality System Maintenance: Update records in the digital quality management system (DQMS) and track through to closure.
  • Data Collection and Analysis: Collate and verify objective evidence for inspection & audit driven CAPAs/EVs, and data entry into the risk assessment tool using risk assessment methodology.
Requirements:
  • Education and Experience: Degree educated with proven experience in the Pharma/Biotech sector, preferably as an auditor in Good Pharmacovigilance Practice (GPvP) or Good Clinical Practice (GCP).
  • Regulatory Knowledge: Solid understanding of global regulatory requirements for GPvP/GCP/observational research.
  • Communication Skills: Excellent oral and written communication skills, with some knowledge of statistical programming tools a plus.
Work Environment:

We offer the option to work fully remote or flexibly from home with occasional office presence at our Cambridge or Uxbridge next-generation workspace.



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