Description
Job Location: Great Britain, United Kingdom
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Not specified
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.
What you will do:
In 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 of potential Sponsor inspections.
- Ensures that a cross-functional team (e.g., Quality, Clinical Operations, other functional areas, PV/GPS, GRAAS, DTI) 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 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).
- Liaises with R&D Quality TA Leads to develop appropriate inspection resourcing/scaling facilities across time zones; aligns TA compliance risk identified contact (CT-RACT) specific risk management items e.g., imaging approaches.
- Supports Regulatory Inspection Intelligence processes; provides input into Operational Quality Initiatives.
Be part of our team:
The Clinical Quality Inspection team is a diverse international team within the Global R&D Quality organization. We are in charge of strengthening and enhancing the R&D Quality Inspection Management System providing quality oversight on R&D processes leading activities related to GCP regulatory inspections.
What we expect of you - Qualifications:
We are all different yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional includes these qualifications and skills:
- Degree Educated
- Extensive experience in inspection management within pharmaceutical or biotechnology industry
- Strong knowledge of global regulatory requirements & inspection processes
- Excellent communication & presentation skills
- Proven ability to work effectively in cross-functional team environment
- Strong organizational & project management skills
- Experience with SharePoint & other inspection management tools
- Ability to provide proactive advice & guidance on inspection management
- Strong problem-solving skills & ability to escalate issues effectively
- Ability to travel domestically/internationally depending on business needs
What you can expect from us:
As we work to develop treatments that take care of others so we work to care for our teammates’ professional/personal growth well-being:
- Vast opportunities learn/move up/across global organization
- 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 flexibly from home regular office work either from Cambridge or Uxbridge next generation workspace. Candidates who do not live within commutable distance have opportunity work fully remotely within United Kingdom.
Apply now! Objects in your future are closer than they appear. Join us at careers.amgen.com
Amgen is an Equal Opportunity employer considering applicants 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 benefits privileges employment please contact request accommodation.
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