Senior Manager, In-Vitro Diagnostics/Precision Medicine Quality
Amgen
Summary
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. This role is responsible for supporting 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.
Job description
Responsibilities
- 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 managing 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 best practices and all regulations are complied 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.
- 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 contributes 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.
Basic 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
Preferred Qualifications
- 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 that includes quality oversight (e.g., deviation management/CAPA, audit conduct, or inspection support).
- Working knowledge of IVD medical device development (i.e. design controls) 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.
- 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 high performing team.
Requirements
- 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
- 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 that includes quality oversight (e.g., deviation management/CAPA, audit conduct, or inspection support).
- Working knowledge of IVD medical device development (i.e. design controls) 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.
- 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 high performing team.
Benefits
- Retirement and Savings Plan
- Medical, Dental & Vision
- Life and Disability Insurance
- Flexible Spending Accounts
- Annual Bonus Program
- Stock-based Long-term Incentives
- Paid Time Off
- Flexible Work Models
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.