R&D Quality Senior Manager
2 semanas atrás
.If you feel like you're part of something bigger, it's because you are.
At Amgen our shared mission—to serve patients—drives all that we do.
It is key to our becoming one of the world's leading biotechnology companies.
We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide.
It's time for a career you can be proud of.
Join us.R&D Quality Senior ManagerWhat you will doIn this vital role, the R&D Quality Senior Manager will play a crucial part in ensuring our organization's compliance with regulatory standards and preparing and coordinating a cross-functional team for Regulatory Health Authority inspections globally.
The role also involves developing inspection management plans for each identified Regulatory Health Authority inspection, managing the R&D inspection framework, and ensuring appropriate inspection resourcing and alignment across time zones.
Additionally, the individual will support Regulatory Inspection Intelligence processes and contribute to operational quality initiatives.Responsibilities:Ensures that, because of inspection preparation activities, story boards are being developed for key processes and activities.
Organizes presentations of the story boards and mock interviews in preparation for potential Sponsor inspections.Ensures that a cross-functional team (e.G.
Quality, Clinical Operations, other functional areas, PV/GPS, GRAAS, DTI, etc.)
is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide.Acts as the subject matter expert and primary point of contact for relevant functional areas on Inspection Management to provide real-time, proactive advice and guidance.Escalates potentially significant inspection findings/compliance risks/impact to Senior Management.Develops the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team.Manages the R&D inspection Framework (Calendars, Distribution Lists, Inspection notifications, SharePoint Sites, Training Content, etc.
).Liaises with R&D Quality TA Leads to develop appropriate inspection resourcing/scaling and facilities across time zones, and align TA compliance risk identified contact (CT-RACT, specific risk management items e.G.
imaging approaches).Supports Regulatory Inspection Intelligence processes and provides input into Operational Quality Initiatives.Be part of our teamThe Clinical Quality Inspection 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 Inspection Management System, providing Quality oversight on R&D processes, and leading activities related to GCP regulatory inspections.What we expect of youWe are all different, yet we all use our unique contributions to serve patients
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