Quality Associate Director

Amgen•Thousand Oaks, CA

21h

About The Position

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 Associate Director What you will do Let’s do this! Let’s change the world! In this vital role, you will serve as Amgen’s operations enterprise leader for the Supplier Quality Management (SQM) Quality Management System (QMS) processes. Reporting to the Business Performance & Quality Management System Leader, you will drive the global SQM strategy, lead digital transformation through DQMS and AI-enabled capabilities, and ensure consistent, compliant, and inspection-ready SQM execution across Amgen’s global operations and affiliate network. You will also shape and govern end-to-end SQM processes ensuring Amgen remains aligned with regulatory expectations and positioned for Quality 2032 ambitions. As Quality Associate Director, Global Process Owner – Supplier Quality Management (SQM), you will:

Requirements

Doctorate degree and 3 years of Quality, Operations, or relevant biopharmaceutical experience OR Master’s degree and 7 years of Quality, Operations, or relevant biopharmaceutical experience OR Bachelor’s degree and 9 years of Quality, Operations, or relevant biopharmaceutical experience OR Associate’s degree and 12 years of Quality, Operations, or relevant biopharmaceutical experience OR High school diploma / GED and 14 years of Quality, Operations, or relevant biopharmaceutical experience
a minimum of 3 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.

Nice To Haves

10+ years of experience in Quality Systems, Supplier Quality, QMS governance, Operations, or related GxP functions.
Experience leading enterprise QMS or digital transformation programs , ideally involving automation, AI, data analytics, and advanced digital tools.
Strong knowledge of global health authority expectations , industry standards, and procedures for SQM and QMS.
Track record leading multi-site, cross-functional initiatives with strategic impact.
Demonstrated success in process ownership , governance, and global standardization.
Experience supporting inspections and audits , with deep understanding of inspection readiness strategies.
Ability to influence and collaborate with senior leaders, external partners, and global teams across varying cultures, functions, and sites.
Excellent communication skills with the ability to simplify complex quality concepts and gain alignment across diverse participants.
Strong critical thinking, change leadership, and problem-solving capabilities in highly matrixed organizations.
Demonstrated success driving continuous improvement and operational excellence across complex, distributed networks.

Responsibilities

Provide enterprise leadership, governance, and decision making for the SQM QMS, including global standards, end-to-end process design, and oversight across Amgen manufacturing sites, above site organizations, global affiliates, and key external partners.
Drive transformation of SQM capabilities by driving key decisions for Digital QMS (DQMS) initiatives, advancing digital tools, automation, AI, and analytics to enhance efficiency, maturity, and compliance.
Lead integration of multiple SQM sub-processes including Event Notifications, Supplier Corrective Actions, and Supplier Change Notifications into one comprehensive, streamlined enterprise workflow.
Oversee the design, implementation, and sustainment of technical releases that enable continuous evolution of the SQM digital ecosystem and support enterprise inspection readiness.
Guide cross-functional alignment by partnering with global sites and operations above site functional areas to ensure SQM processes support business needs and regulatory expectations.
Ensure enterprise inspection readiness for SQM by establishing robust KPIs, monitoring systems, dashboards, and governance mechanisms to predict risks, improve issue management, and support the high number global audit and inspection engagements annually.
Lead SQM integration of new sites, programs, and acquisitions , including Rare Disease and future portfolios, ensuring seamless adoption, harmonization, and sustainable SQM capabilities.
Develop and implement enterprise change management and communication strategies to support adoption of new technologies, standards, and processes across global functions and supplier partners for the SQM QMS and related processes.
Represent SQM globally with regulators, partners, and industry forums to advance standard processes, benchmark performance, and ensure the QMS remains current with evolving expectations.
Cultivate a high-performing network of SQM team members , providing guidance to senior professionals across multiple departments and sites.
Directly manage a hard-working team of quality professionals to advance SQM aligned with Quality Strategy for 2032 ambitions.

Benefits

health and welfare plans for staff and eligible dependents
financial plans with opportunities to save towards retirement or other goals
work/life balance
career development opportunities
Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
life and disability insurance
flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible