Safety and Medical Quality Manager - Observational Research

The Quality Manager in the Safety & Medical Quality organisation will identify compliance issues participate in audits, quality investigations and remediation activities. This role supports Safety and Medical processes, with a focus on Observational research activities. Key responsibilities include supporting the pharmacovigilance (GPvP) annual audit plan, preparing and completing audits, investigating Quality events, and assisting with partner audits and regulatory inspections.,

• Plan, conduct and report on risk-based R&D audits
• Support the completion of the audit plan for GPvP suppliers/vendors and processes
• Support investigations of deviations from GPvP and GCP processes including root cause analysis, design, development or Corrective and Preventive Actions (CAPAs) and Effectiveness Verifications (EVs)
• Update records in the digital quality management system (DQMS) and track through to closure
• Collating and verifying objective evidence for inspection & audit driven CAPAs/EVs
• Data entry into the risk assessment tool (using risk assessment methodology)
• Support GxP audits from business partners, GxP inspection readiness and inspection management activities
• Support R&D Quality governance in clinical development, pharmacovigilance and/or observational research
• Assist with audit planning meetings, debriefs, audit plan outlines and response reviews
• Maintain knowledge of current regulatory and quality practices/issues
• Collate compliance metrics for presentations to key stakeholders
• Support vendor evaluations related to observational research studies and GPvP or GCP vendors
• Actively seek and implement innovative quality oversight methodologies to improve our processes (e.g. risk-methods using AI and Natural Language Processing, and data analytics)
JOIN OUR TEAM The Safety and Medical Quality team is a diverse international team within the Global R&D Quality organisation. We are in charge of strengthening and enhancing the R&D Quality Management System, providing Quality oversight on R&D processes, and leading activities related to PV regulatory inspections and audits of the Amgen PV system.


• Degree Educated
• Proven experience in the Pharma/Biotech sector
• Experience as an auditor, preferably in Good Pharmacovigilance Practice (GPvP) or Good Clinical Practice (GCP)
• Solid understanding of global regulatory requirements for GPvP/GCP/ observational research
• Experience in supporting GPvP/GCP audits or inspections
• Outstanding oral and written communication skills.
• Some knowledge of statistical programming tools, such as STATA or SAS would be a plus
  
  At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission-to serve patients-has driven our status as one of the world's preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.
  
  As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
• Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits