Associate Vice President, Quality

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

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.

Associate Vice President, Quality

What you will do

Let’s do this. Let’s change the world. In this vital role as Associate Vice President, Quality you will report to the Vice President Research and Development Quality (RDQ) Organization (a team of 30-40 staff will be built to serve Amgen’s Research Development Organization).

The Associate Vice President, Quality will lead and provide proactive end to end quality strategies globally for therapeutic areas: Oncology, Inflammation, Cardiovascular, Neuroscience and others. This role will drive the transformation of clinical quality oversight in compliance with ICH E6R3 and enable embedded quality oversight into clinical development teams. Incorporate quality by design principles to ensure quality risk management is identified and mitigated early to drive a high degree of compliance throughout the study conduct. Deliver inspection strategies to ensure successful submissions globally.

This role builds collaborative supportive relationships and serves as single point of accountability representing RDQ with the Amgen clinical, research, clinical operations, regulatory and other relevant stakeholders in Research and Development (R&D) and Operations Quality in support of the therapeutic area for which they are responsible.

Responsibilities

• Ensures proper quality oversight strategies of research activities and RBQM in clinical trials.

• Lead a global team and manage all trials across the Amgen portfolio globally.

• RDQ has a key role and responsibility in driving embedded quality partnerships across critical R&D programs.

• RDQ has a key role in advancing data driven oversight capability across the organization.

• Responsible for inspection readiness, inspection execution and follow up.

Clinical

• Expanding our capabilities beyond GCP compliance and audit mindset focus include:

  • Biosimilars

  • Rare Disease

  • Precision Medicine

  • Digital technology

  • Labelling

  • Product Complaint/Safety Reporting

  • PASS Study Management

  • Clinical trial simplification

  • Data analytics

  • Metrics development

  • R&D activities in response to regulatory trends and external pressures

• Quality and compliance oversight over Amgen General Medicine: cardiovascular, obesity; Oncology, Inflammation and Biosimilar Portfolios

• RDQ is transforming into an organization that provides quality assurance through proactive quality oversight in clinical trials on quality by design, critical to quality measures and risk-based quality assurance. 

• Oversight of FSP and ensures performance of vendors is adequately executed for each study.

• Leads health authority inspection readiness and inspection strategy for clinical globally.

Research

• Expanding our capabilities beyond GLP compliance mindset to include:

  • In-Vitro and Companion Diagnostics

    • Biomarkers

    • Lab services

    • Digital technology

    • Data analytics

• Research studies internally and externally sourced.

• Research vendors including innovative technology vendors, lab facilities.

• Animal welfare.

• Health authority inspection readiness and inspection strategy for research

What we expect