[Hiring] Senior Manager, In-Vitro Diagnostics/Precision Medicine Quality @Amgen

Role Description

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

• 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 Tests (LDTs), and assays.
• Support clinical trial inspections from health authorities, including inspection readiness and managing findings.
• Collaborate with Amgen’s IVD and diagnostic partners to ensure quality oversight of IVDs/assays used within Amgen drug clinical trials.
• Support the IVD/CDx team and collaborators to advance IVD/CDx quality management strategies.
• Provide support for Quality Agreements, clinical trial protocol review, Informed Consent form reviews, and IRB application review.
• Support EU Clinical Performance Studies and US IDE requirement implementation.
• Contribute to the collection and use of metrics related to IVD and Precision Medicine for Quality Management System performance and improvement.
• Maintain up-to-date knowledge of IVD regulations and applicable guidance.
• Provide risk-based quality assurance and oversight for IVD/Precision Medicine activities.
• Ensure that all applicable integrated procedures are fit for purpose and aligned to Amgen’s standards.

Qualifications

• Doctorate degree and 2 years of quality, regulatory or Companion Diagnostic experience OR
• Master’s degree and 4 years of quality, regulatory, or Companion Diagnostic experience OR
• Bachelor’s degree and 6 years of quality, regulatory, or Companion Diagnostic experience OR
• Associate’s degree and 10 years of quality, regulatory, or Companion Diagnostic experience OR
• High school diploma / GED and 12 years of quality, regulatory, or Companion Diagnostic experience

Requirements

• Experience within the 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 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.
• Working knowledge of IVD medical device development and applicable Global Regulations related to companion diagnostics.
• 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.
• Experience with compliance to GxP requirements including oversight of third-party vendors, suppliers, and partners.
• Strong analytical, critical-thinking, and decision-making abilities.
• Innovative thinking, including the application of quality by design principles.
• Collaborative worker with an ability to support a high performing team.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.
• Group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.

Company Description

Amgen is dedicated to improving the quality of life for people around the world, fostering an inclusive environment of ethical, committed, and highly accomplished people who respect each other and live the Amgen values.