Quality Associate Director
Amgen
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $158,812 - $185,145 per year
Job Level
About the role
- Serve as Amgen’s operations enterprise leader for the Supplier Quality Management (SQM) Quality Management System (QMS) processes
- Drive the global SQM strategy and lead digital transformation through DQMS and AI-enabled capabilities
- Ensure consistent, compliant, and inspection-ready SQM execution across Amgen’s global operations and affiliate network
- Shape and govern end-to-end SQM processes to ensure alignment with regulatory expectations
- Provide enterprise leadership, governance, and decision making for the SQM QMS, including global standards and oversight across Amgen manufacturing sites
- Drive transformation of SQM capabilities through digital tools, automation, AI, and analytics
- Lead integration of multiple SQM sub-processes into one comprehensive enterprise workflow
- Oversee the design, implementation, and sustainment of technical releases for SQM digital ecosystem
- Guide cross-functional alignment with global sites and operations
- Ensure enterprise inspection readiness for SQM by establishing robust KPIs and governance mechanisms
- Lead SQM integration of new sites, programs, and acquisitions
- Develop and implement enterprise change management and communication strategies
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
- Minimum of 3 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
- 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
- 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
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality Management System (QMS)Supplier Quality Management (SQM)digital transformationautomationAIdata analyticsprocess ownershipgovernanceinspection readinesscontinuous improvement
Soft Skills
leadershipcommunicationcritical thinkingchange leadershipproblem-solvingcollaborationinfluencealignmentstrategic impactcross-functional teamwork