Senior Manager, In-Vitro Diagnostics/ Companion Diagnostics/ Precision Medicine Quality

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Senior Manager, In-Vitro Diagnostics/ Companion Diagnostics/ Precision Medicine Quality

LIVE

What will you do

In this role you will report to the Director of Precision Medicine and Diagnostics within R&D Quality. This role supports the use of In-Vitro Diagnostics (IVD), including Companion Diagnostics (CDx), within Amgen’s global clinical trials.

This role will support the implementation of a proactive and risk-based Quality strategy for IVD medical devices, including collaborations with diagnostic partners and testing laboratories.

The Precision Medicine and Diagnostic Quality strategy is focused on all aspects of research and development at Amgen, spanning from discovery through the entire lifecycle of clinical development.

In this vital role you will:

• Support quality oversight of IVD medical devices used within Amgen’s precision medicine and digital medicine clinical trials
• Provide subject matter expertise on the regulatory and quality oversight of
  IVDs, including CDx, Laboratory Developed Test (LDTs), assays, within the areas of precision and digital medicine
• Support clinical trial inspections from health authorities (including inspection readiness and leading findings). This includes drug and device inspections.
• Collaborate with Amgen’s IVD and diagnostic partners to ensure quality oversight of IVDs/ assays used within Amgen drug clinical trials to ensure industry guidelines and all regulations are aligned with.
• Supports the IVD/ CDx team and collaborators to ensure that IVD/ CDx quality management strategies are advanced related to the evolving and complex IVD regulatory landscape, including the EU and US.
• Conduct audits of IVD partners to ensure compliant QMS and devicemanufacturing. 
• Provide support for Quality Agreements, clinical trial protocol review, Informed Consent form reviews, IRB application review.
• Provide support for EU Clinical Performance Studies and US IDE requirement implementation.
• Understands and participates to the collection and use of metrics (KQI, KPI leading and lagging) related to IVD and Precision Medicine for Quality Management System performance and improvement.
• Maintains up-to-date knowledge of IVD regulations and applicable guidance; monitor development of regulations and communicate impact to the business.
• Provides risk-based quality assurance and oversight for IVD/ Precision Medicine activities (e.g., auditing, deviation management and inspection management).
• Ensures that all applicable integrated procedures (e.g., acquired assets) are fit for purpose and aligned to Amgen’s standards.

WIN

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we are looking for meets these criteria:

Minimum requirements

• PhD or Msc or Bsc or High school diploma
• Around 8 years of experience in quality, regulatory or clinical trials management in pharmaceutical/ biotech, medical device, and/or biomarker industry
• Working with In-Vitro Diagnostics (IVD) and preferably Companion Diagnostic (CDx) devices.
• Experience at EU clinical trial sites, either as a site monitor or study management.
• Experience conducting audits and/or participating in health authority inspections.
• Ability to incorporate business and team member feedback into clear, efficient processes using a straightforward language and format.
• Strong analytical, critical-thinking, and decision-making abilities, including development and implementation of Analytics methods and technology in order to enable signal detection and quality improvement.
• Innovative thinking, including the application of quality by design principles.
• Collaborative worker with an ability to support a hard-working team.
• Fluency in English.

Preferred requirements

• Experience working with Companion Diagnostics/ assay development for the pharmaceutical industry/ CLIA cert and/or ISO 15189 cert labs/ biomarker testing.
• Experience working in a quality management system role, or other relevant experience in a clinical research environment that includes quality oversight (e.g., deviation management/CAPA, audit conduct, or inspection support).
• An understanding of IVD medical device development and applicable Global Regulations related to use of companion diagnostics and assay development in precision medicine (including EU IVDR, FDA CDx Final Rule).
• An understanding of Precision Medicine and applicable Global Regulations.
• Understanding of EU IVD performance studies under EU IVD Regulation.
• An understanding of Quality Management Systems (QMS), including electronic QMS such as Veeva or TrackWise (Sparta Systems).
• Experience with compliance to GxP requirements including the oversight of third-party vendors, suppliers, and partners.

THRIVE

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,

• Flexible work arrangements, including hybrid opportunities

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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, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request an accommodation.