Senior Manager, In-Vitro Diagnostics, Precision Medicine Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide oversight for quality assurance of IVD medical devices utilized in Amgen’s precision and digital medicine clinical trials.

• Offer expertise on the regulatory and quality aspects of IVDs, including Companion Diagnostics (CDx), Laboratory Developed Tests (LDTs), and assays.

• Assist in clinical trial inspections conducted by health authorities, ensuring readiness and managing findings effectively.

• Collaborate with partners in IVD and diagnostics to guarantee compliance with quality and regulatory standards.

• Enhance IVD/CDx quality management strategies to keep pace with the changing regulatory environment in the EU and US.

• Aid in the development of Quality Agreements, review clinical trial protocols, informed consent forms, and IRB applications.

• Support the execution of EU Clinical Performance Studies and the implementation of US IDE requirements.

• Contribute to the gathering and utilization of Key Quality Indicators (KQI) and Key Performance Indicators (KPI) for the enhancement of the Quality Management System.

• Stay updated on IVD regulations and guidelines; track regulatory changes and communicate their implications for the business.

• Deliver risk-based quality assurance and oversight, including auditing, managing deviations, and inspection processes.

• Ensure that integrated procedures are appropriate and comply with Amgen's standards.

• Report directly to the Director of Precision Medicine and Diagnostics Quality within the R&D Quality department.

⛳️ Requirements

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

• Experience in the pharmaceutical/biotech, medical device, and/or biomarker sectors, specifically with In-Vitro Diagnostics (IVD) and ideally with Companion Diagnostic (CDx) devices.

• Experience at EU clinical trial sites, either in a monitoring role or study management.

• Worked with Companion Diagnostics/assay development in the pharmaceutical industry, CLIA certified labs, and/or ISO 15189 certified labs/biomarker testing.

• Experience in a quality management system role or relevant clinical research setting with a focus on quality oversight.

• Knowledge of IVD medical device development processes, particularly design controls.

• Familiarity with global regulations governing companion diagnostics and assay development, including EU IVDR and FDA CDx Final Rule.

• Understanding of Precision Medicine and relevant global regulations.

• Knowledge of EU IVD performance studies in accordance with EU IVD Regulation.

• Familiarity with Quality Management Systems (QMS), including electronic QMS platforms like Veeva or TrackWise.

• Experience with GxP standards and overseeing third-party vendors, suppliers, and partners.

• Ability to integrate feedback into streamlined, effective processes.

• Strong analytical, critical-thinking, and decision-making skills.

• Proven experience in developing and implementing analytical methods and technologies for signal detection and quality enhancement.

• Innovative mindset, particularly in applying quality by design principles.

• Capability to work collaboratively and contribute to a high-performing team.

🏝️ Benefits

• Comprehensive employee benefits package.

• Retirement and Savings Plan with substantial company contributions.

• Group medical, dental, and vision insurance coverage.

• Life and disability insurance.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off policies.

• Flexible work arrangements where feasible.

• Opportunities for career advancement.

• Financial plans providing options to save for retirement or other objectives.

• Work/life balance.