Executive Director, Product 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. 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.

Executive Director, Product Quality

Live

What you will do

Let’s do this. Let’s change the world. In this vital role as the Executive Director, Product Quality, you will provide strategic and technical leadership to ensure the highest standards of product quality across multiple late-phase clinical and commercial programs.

This role demands a deep understanding of Amgen’s Quality systems and commercialization processes, cGMP and international regulatory expectations, as well as the ability to respond to emerging scientific and technical trends that impact the organization.

The successful candidate will manage and mentor team members, lead cross-functional initiatives, and represent Product Quality in cross-functional teams to drive continuous improvement and maintain compliance. 

Key Responsibilities

• Manage Directors and additional staff supporting the Product Quality work center teams responsible for deliverables for multiple late-phase clinical or commercial programs

• Advise on CMC strategies and quality risk management for commercialization including strategies for in process controls, specifications, stability, and comparability

• Provide functional and cross-functional review of regulatory CMC submission content

• Serve as a mandatory attendee for Product Quality-related boards and committees like the PQ Review Board

• Directly manage or influence work groups within the Product Quality organization potentially including Process Owners, Quality Assurance specialists, Stability specialists, or statisticians

• Represent Product Quality at Operations Governance meetings

• Lead projects and cross-functional initiatives seeking transformation or continuous improvement in business processes or quality processes

• Collaborate with cross-functional leaders in Quality, Regulatory Affairs, Process Development, Manufacturing, and Supply Chain to resolve issues and advance business imperatives

• Provide strategic, technical, and compliance guidance to cross-functional teams supporting commercialization and lifecycle management of Amgen products and addressing critical investigations

Technical, Leadership and Influence

• Engage with and influence Executive Management, mentor and advise staff

• Serve as decision maker, advisor, and stakeholder using the DAI model

• Proficiency in knowledge of cGMP and international regulatory expectations

• Understanding and responding to the impact of emerging scientific/technical trends and their implications for Amgen

• Actively mentoring new and existing team members to develop core Product Quality skills and leadership skills

• Engage with Amgen colleagues, industry peers, and workgroups to advance Amgen technical CMC perspectives

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What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an experienced leader with the following qualifications.

Basic Qualifications:

• Doctorate Degree & 6 years of Quality, Operations, Scientific or Manufacturing experience, OR 

• Master's Degree & 10 years of Quality, Operations, Scientific, or Manufacturing experience, OR 

• Bachelor's Degree & 12 years of Quality, Operations, Scientific, or Manufacturing experience, AND  

• Six years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources  

Preferred Qualifications: