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 Manager
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 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 team
The 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 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 and skills:
Degree Educated
Extensive experience in inspection management within the pharmaceutical or biotechnology industry.
Strong knowledge of global regulatory requirements and inspection processes.
Excellent communication and presentation skills.
Proven ability to work effectively in a cross-functional team environment.
Strong organizational and project management skills.
Experience with SharePoint and other inspection management tools.
Ability to provide proactive advice and guidance on inspection management.
Strong problem-solving skills and the ability to escalate issues effectively.
Ability to travel domestically and/or internationally, depending on business needs, to attend inspections as needed.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization.
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.
LOCATION:
Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace. Candidates who do not live within a commutable distance have the opportunity to work fully remotely within the United Kingdom. Apply now Objects in your future are closer than they appear. Join us. careers.amgen.com Amgen 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 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 accommodation.
#J-18808-Ljbffr
Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace. Candidates who do not live within a commutable distance have the opportunity to work fully remotely within the United Kingdom. Apply now Objects in your future are closer than they appear. Join us. careers.amgen.com Amgen 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 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 accommodation.
#J-18808-Ljbffr
