Inspection Readiness Manager

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION

If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

INSPECTION READINESS MANAGER

LIVE

What you will do

In this vital role you will lead GCP and IVDR Inspection Readiness and Preparation activities across Amgens clinical portfolio including early-phase late-phase and observational studies. You will drive inspection readiness strategies oversee site inspection preparation projects and partner cross-functionally to strengthen operational quality support successful regulatory inspections and promote continuous improvement across the organization.

• Lead GCP and IVDR site inspection readiness and preparation activities ensuring consistent execution and successful inspection outcomes.
• Manage inspection readiness tools systems materials and regulatory inspection preparation processes.
• Drive continuous improvement initiatives by identifying quality trends risks and inspection learnings and implementing effective solutions.
• Partner with the Inspection Readiness Support Team to advance study health quality and inspection readiness initiatives.
• Serve as a subject matter advisor on inspection readiness and support selected internal audit activities.
• Maintain inspection readiness SharePoint resources inspection documentation repositories and access management.
• Support the Inspection Readiness & Operational Quality Senior Manager in strategic and operational activities.
• Mentor and develop student interns.

Be part of our team

You would be joining the Operational Quality team who supports Clinical Program Operations by providing inspection readiness Trial Master File and clinical trial risk management expertise to ensure compliance with ICH GCP. Through these activities the team helps protect trial participant rights safety and well-being while ensuring the integrity quality and credibility of clinical trial data.

WIN

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
• Work experience in life sciences or medically related field including biopharmaceutical clinical research experience working on clinical trials at a biotech pharmaceutical or CRO company
• Experience of or oversight of global clinical trial conduct
• Experience driving and leading process development and /or improvement
• Experience as an Inspection or Risk Manager is preferred
• Mandarin language is preferred but not mandatory

THRIVE

What you can expect of us

As 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.

• 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.

APPLY NOW

for a career that defies imagination

In our quest to serve patients above all else Amgen is the first to imagine and the last to doubt. Join us.

Equal Opportunity Statement

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 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.