Quality Assurance Senior Manager

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Quality Assurance Senior Manager

What you will do

Let’s do this! Let’s change the world! 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.

• Participate in the update, integration, and configuration of Amgen technology to ensure compliance with relevant standards and 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

• Willing and able to travel up to 15%

Authority

• Advise program teams as Quality representative as required (fungible resource)

• Review and provide input to on-topic global regulatory guidance, verification and validation documentation for HTPs or diagnostics

• Conduct gap analyses