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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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.
Job Responsibility
Develop and execute a multi-year Operational Excellence roadmap aligned to R&D Quality strategy and enterprise priorities
Establish and lead governance processes for the R&D Quality including operating reviews, strategic planning cycles, decision forums, and escalation pathways
Drive R&D GXP quality governance models to ensure adequate quality performance and escalation from L2 through L0
Support Global Quality efforts, representing R&D quality, on quality governance as needed
Drive annual goal setting, portfolio prioritization, budget tracking, and business performance reviews
Identify and lead/monitor cross-functional improvement initiatives across audits/inspections, quality systems, CAPA, supplier quality, and oversight models
Establish project management standards, tools, and governance for strategic Quality initiatives
Lead a portfolio of enterprise and functional projects ensuring scope, timelines, resources, risks, and deliverables are managed
Represent R&D Quality in acquisition assessments, licensing opportunities, and strategic partnerships
Lead Quality due diligence and execute post-close integration plans for acquired assets
In partnership with Global Development, establish KPIs to measure quality performance, efficiency, risk, and project delivery
Build operational excellence and project management capability through coaching, training, and mentoring
Act as a trusted advisor to senior leaders, bringing insights and thought leadership on operational performance
Demonstrate foresight in identifying emerging challenges and opportunities
Navigate ambiguity with confidence and agility, aligning teams and stakeholders around a common transformation vision
Requirements
Doctorate degree and 5 years of experience in Quality Assurance or Strategy in a regulated industry OR Master’s degree and 9 years of experience in Quality Assurance or Strategy in a regulated industry OR Bachelor’s degree and 11 years of experience in Quality Assurance or Strategy in a regulated industry
In addition to meeting at least one of the above requirements, you must have at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
Nice to have
Strong knowledge of GxP regulations including GCP, GLP, PV, and quality system management
Demonstrated success leading enterprise transformation, governance and complex integration programs
Strong executive presence with ability to influence senior stakeholders
Advanced degree (MBA, MS in Operations/Engineering, or similar)
Certification in Lean Six Sigma (Black Belt or Master Black Belt)
Demonstrated expertise in designing and implementing KPIs and performance management frameworks
Strong financial and business acumen
capable of building business cases and measuring ROI
High EQ, exceptional communication skills, and experience consulting with senior stakeholders
Strategic mindset with operational execution capabilities—able to align vision with delivery
Experience integrating data science, AI, or digital tools in operational settings
Comfortable with ambiguity and rapid change
thrives in a matrixed, global organization
What we offer
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