R&D Quality Senior Manager

at  Amgen

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 read over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
R&D Quality Senior Manager

• 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 of 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.
• Manage the R&D inspection Framework (Calendars, Distribution Lists, Inspection notifications, SharePoint Sites, Training Content, etc…).
• Liaise 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) .
• Support Regulatory Inspection Intelligence processes and provide input into Operational Quality Initiatives.