Amgen

Quality Assurance Senior Manager

Amgen

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $141,158 - $164,599 per year

Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • In the rapidly evolving landscape of clinical trials, ensuring the quality and compliance of innovative technologies is paramount.
  • This role reports to the Executive Director, Precision Medicine/Diagnostics and R&D Supplier Quality, and is dedicated to supporting the implementation of a comprehensive and proactive Quality Assurance (QA) strategy for diagnostic or health technology products used in Clinical Trials, including third-party collaborations and oversight.
  • The individual in this role is crucial in managing and overseeing programs and projects related to R&D supplier/service provider quality, diagnostics, imaging, digital pathology, AI models, and health tech products used for decentralized Clinical Trials and others.
  • The responsibilities include continuous improvement, operational programs, systems, and procedures to ensure compliance with requirements, standards, and regulatory expectations while employing risk-based, scalable approaches.
  • The Quality strategy surrounding clinical trials' technology is relevant in all aspects of research and development at Amgen, spanning from early research through the entire lifecycle of clinical development.
  • This strategy will ensure that Amgen’s procedures meet internal and external quality standards, and that they are managed for optimum efficiency and effectiveness.
  • This strategy also ensures that the business develops and manages fit for purpose standards (SOPs and quality agreements).
  • In addition, the strategy will ensure that Amgen’s QMS is continuously improved upon using quality by design, risk assessments, and outputs from the Quality Management System, including analytics showing quality trends and potential continuous improvement opportunities.
  • Key Responsibilities Develop collaborative partnerships with Research and Development (R&D) to help establish the state of quality and potential areas of quality risk exposure.
  • Contributes to the use of innovative methods for improving the quality oversight for regulated device technologies and suppliers used in Amgen’s clinical programs.
  • Collaborate with colleagues in a cross-matrixed environment and ensure that Amgen’s R&D efforts, including partnerships and third parties, are aligned to industry standard methodologies and all regulations.
  • Develop and implement AI-based solutions to advance continuous process improvement and efficiencies
  • Leverage metrics (KQI, KPI leading and lagging) to drive performance and improvement
  • Maintain up-to-date knowledge of relevant regulations and applicable guidance and communicate impact to the business.
  • Perform upstream and downstream performance and compliance analysis to identify potential risks.
  • Represent Quality on innovative health technology or diagnostic programs and initiatives as assigned
  • Assist other R&D Quality groups in properly channeling related items to the appropriate processes and controls
  • Conduct assessments, audits, and Quality investigations
  • Oversee department infrastructure operations, metrics, and operational excellence
  • Facilitate inspection readiness, conduct, and follow-through for responsibilities in scope

Requirements

  • Doctorate degree and 2 years of Quality Management or other relevant experience
  • Master’s degree and 4 years of Quality Management or other relevant experience
  • Bachelor’s degree and 6 years of Quality Management or other relevant experience
  • Associate’s degree and 10 years of Quality Management or other relevant experience
  • High school diploma / GED and 12 years of Quality Management or other relevant experience
  • At least 3 years of experience in medical device or pharmaceutical/biotech industry working within a quality management system role, or other relevant experience in clinical research that includes quality oversight (e.g., deviation management/CAPA, audit conduct, or inspection support.)
  • An understanding of applicable Global Regulations.
  • An understanding of Quality Management Systems (QMS), including electronic QMS such as Veeva
  • Experience preferred working within research and development
  • Implementation of technology in a diverse R&D environment
  • Experience with compliance to GCP requirements including interaction with third-party vendors, suppliers, and partners
  • Ability to use artificial intelligence (AI) tools and technologies to streamline workflows, drive process automation, and support data-driven decision-making.
  • Adept at finding opportunities to apply AI for operational efficiency and continuous improvement initiatives
  • 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 signal detection that drives quality improvement
  • Innovative thinking, including the application of quality by design principles
  • Collaborative worker with an ability to support a hard-working team
  • Excellent verbal and written communication skills, including strong business writing abilities and active listening
  • Deep experience with investigation, CAPA change management, pre- and post-mortems, and problem-solving methodologies
  • Willingness to learn and be persistent
  • Willing and able to travel up to 15%