Description
Job Location: Great Britain, United Kingdom
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Not specified
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.
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
- 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 GPvP or GCP vendors
- Actively seek implement innovative quality oversight methodologies to improve our processes (e.g., risk-methods using AI Natural Language Processing data analytics)
JOIN OUR TEAM
The Safety Medical Quality team is a diverse international team within Global R&D Quality organisation. We are in charge of strengthening enhancing R&D Quality Management System providing Quality oversight on R&D processes leading activities related PV regulatory inspections audits Amgen PV system.
What We Expect Of You
We are all different yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional are these qualifications skills:
- Degree Educated
- Proven experience in Pharma/Biotech sector
- Experience as auditor preferably Good Pharmacovigilance Practice (GPvP) Good Clinical Practice (GCP)
- Solid understanding global regulatory requirements for GPvP/GCP/observational research
- Experience supporting GPvP/GCP audits inspections
- Outstanding oral written communication skills
- Some knowledge statistical programming tools such STATA SAS would be plus
What You Can Expect Of Us
As we work develop treatments that take care others so we work care our teammates’ professional personal growth well-being.
- Clear disciplined strategic vision future leverages superior-quality products operational excellence top-shelf-talent
- Diverse inclusive community belonging where teammates empowered bring ideas table act
- Generous Total Rewards Plan comprising health finance wealth work/life balance career benefits
LOCATION: Ability work fully remote if situated near office option work flexibly home occasional office presence at Cambridge Uxbridge next-generation workspace.
APPLY NOW
What we do hard should be We working each other against challenges today promise tomorrow Lead way.careers.amgen.com
Equal Opportunity Statement
Amgen is Equal Opportunity employer will consider you without regard race color religion sex sexual orientation gender identity national origin protected veteran status disability status.We ensure individuals disabilities provided reasonable accommodation participate job application interview process perform essential job functions receive other benefits privileges employment Please contact us request accommodation.Lifelancer is talent-hiring platform Life Sciences Pharma IT The platform connects talent opportunities pharma biotech health sciences healthtech IT domains.For more details find similar roles please check out below Lifelancer link.Apply Lifelancer Platform