Amgen · 13 hours ago
Quality Associate Director
United States
Full-time
Remote
Lead/Staff, Director/Executive
9+ years expAmgen is a biotechnology company dedicated to serving patients living with serious illnesses. In this role, you will lead the Supplier Quality Management processes, drive digital transformation initiatives, and ensure compliance across Amgen's global operations.
BiotechnologyHealth CareManufacturingPharmaceutical
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
Qualification
Required
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
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
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
Benefits
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and 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.
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
2026-01-22
2026-01-20
Company data provided by crunchbase