Safety and Medical Quality Manager – Observational Research

Job title:

Safety and Medical Quality Manager – Observational Research

Company

Amgen

Job description

Career Category ComplianceJob DescriptionAt 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 RESEARCHLIVEWhat you will doThe 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 auditsSupport the completion of the audit plan for GPvP suppliers/vendors and processesSupport 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 closureCollating and verifying objective evidence for inspection & audit driven CAPAs/EVsData entry into the risk assessment tool (using risk assessment methodology)Support GxP audits from business partners, GxP inspection readiness and inspection management activitiesSupport R&D Quality governance in clinical development, pharmacovigilance and/or observational researchAssist with audit planning meetings, debriefs, audit plan outlines and response reviewsMaintain knowledge of current regulatory and quality practices/issuesCollate compliance metrics for presentations to key stakeholdersSupport vendor evaluations related to observational research studies and GPvP or GCP vendorsActively 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 TEAMThe 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.WINWhat we expect of youWe 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 and skills:Degree EducatedProven experience in the Pharma/Biotech sectorExperience as an auditor, preferably in Good Pharmacovigilance Practice (GPvP) or Good Clinical Practice (GCP)Solid understanding of global regulatory requirements for GPvP/GCP/ observational researchExperience in supporting GPvP/GCP audits or inspectionsOutstanding oral and written communication skills.Some knowledge of statistical programming tools, such as STATA or SAS would be a plusTHRIVEWhat you can expect of usAs 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-talentDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefitsLOCATION: 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.APPLY NOWWhat we do is hard. It should be. We are working with each other against the challenges of today for the promise of tomorrow. Lead the way.careers.amgen.comEqual Opportunity StatementAmgen 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..

Expected salary

Location

United Kingdom

Job date

Thu, 05 Dec 2024 07:47:01 GMT

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