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.
SAFETY AND MEDICAL QUALITY MANAGER - OBSERVATIONAL RESEARCH
What you will do
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.
Primary responsibilities:
1. Plan, conduct and report on risk-based R&D audits
2. Support the completion of the audit plan for GPvP suppliers/vendors and processes
3. 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)
4. Update records in the digital quality management system (DQMS) and track through to closure
5. Collate and verify objective evidence for inspection & audit driven CAPAs/EVs
6. Data entry into the risk assessment tool (using risk assessment methodology)
7. Support GxP audits from business partners, GxP inspection readiness and inspection management activities
8. Support R&D Quality governance in clinical development, pharmacovigilance and/or observational research
9. Assist with audit planning meetings, debriefs, audit plan outlines and response reviews
10. Maintain knowledge of current regulatory and quality practices/issues
11. Collate compliance metrics for presentations to key stakeholders
12. Support vendor evaluations related to observational research studies and GPvP or GCP vendors
13. 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)
What we expect of you
1. Degree Educated
2. Proven experience in the Pharma/Biotech sector
3. Experience as an auditor, preferably in Good Pharmacovigilance Practice (GPvP) or Good Clinical Practice (GCP)
4. Solid understanding of global regulatory requirements for GPvP/GCP/ observational research
5. Experience in supporting GPvP/GCP audits or inspections
6. Outstanding oral and written communication skills.
7. Some knowledge of statistical programming tools, such as STATA or SAS would be a plus
LOCATION: Ability to work fully remote, or, if situated near an office, the option to work flexibly from home with occasional office presence at our Cambridge or Uxbridge next-generation workspace.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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