Quality Associate Director

Role Summary

Quality Associate Director, Global Process Owner – Supplier Quality Management (SQM) serves as Amgen’s operations enterprise leader for the SQM Quality Management System (QMS) processes. The role drives the global SQM strategy, leads digital transformation through DQMS and AI-enabled capabilities, and ensures consistent, compliant, and inspection-ready SQM execution across Amgen’s global operations and affiliate network, shaping end-to-end SQM processes aligned with regulatory expectations and Quality 2032 ambitions.

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 of 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.

Qualifications

• Required: Doctorate degree and 3 years of Quality, Operations, or relevant biopharmaceutical experience OR
• Required: Master’s degree and 7 years of Quality, Operations, or relevant biopharmaceutical experience OR
• Required: Bachelor’s degree and 9 years of Quality, Operations, or relevant biopharmaceutical experience OR
• Required: Associate’s degree and 12 years of Quality, Operations, or relevant biopharmaceutical experience OR
• Required: High school diploma / GED and 14 years of Quality, Operations, or relevant biopharmaceutical experience
• Required: In addition to meeting at least one of the above requirements, a minimum of 3 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.

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

Education

• Doctorate, Master’s, Bachelor’s, Associate’s, or High School diploma with corresponding years of Quality, Operations, or relevant biopharmaceutical experience as listed above.