Senior Director, Operational Excellence
Amgen
3 months ago
Remote friendly (United States)
United States
Operations
Senior Director, Operational Excellence
What You Will Do
- Lead strategy, governance, transformation, and execution of continuous improvement initiatives across R&D Quality.
- Drive scalable, efficient, compliant, data-driven processes enhancing quality oversight across GCP, GLP, GVP, clinical development, pharmacovigilance, laboratories, quality systems, and external partnerships.
- Provide governance frameworks, strategic project management, and quality support for business development (acquisitions, due diligence, post-close integration).
- Partner with Quality leadership and cross-functional teams (R&D, Regulatory Affairs, IT, Finance, HR) to modernize operations and strengthen organizational performance.
Key Responsibilities
- Develop and execute a multi-year Operational Excellence roadmap aligned to R&D Quality strategy.
- Establish governance processes (operating reviews, planning cycles, decision forums, escalation).
- Drive R&D GxP quality governance models with escalation from L2 through L0.
- Lead annual goal setting, portfolio prioritization, budget tracking, and performance reviews.
- Lead/monitor cross-functional improvement initiatives across audits/inspections, quality systems, CAPA, supplier quality, and oversight models.
- Establish project management standards/tools; lead a portfolio ensuring scope, timelines, resources, risks, and deliverables.
- Represent R&D Quality in acquisition assessments, licensing, and strategic partnerships; lead quality due diligence and post-close integration.
- Establish KPIs for quality performance, efficiency, risk, and project delivery.
- Build capability through coaching, training, and mentoring.
Basic Qualifications
- Doctorate + 5 years in Quality Assurance/Strategy in a regulated industry OR Master’s + 9 years OR Bachelor’s + 11 years.
- At least 5 years managing people and/or leading teams/projects/programs or directing resource allocation.
Preferred Qualifications
- Strong GxP (GCP/GLP/PV) and quality system management knowledge.
- Enterprise transformation, governance, complex integration experience.
- Executive influence; advanced degree; Lean Six Sigma Black Belt/Master Black Belt.
- KPI/performance framework expertise; financial/business acumen/ROI.
- High EQ, strong communication; consulting with senior stakeholders.
- Experience integrating data science/AI/digital tools; thrives in ambiguity/matrixed global settings.
Benefits
- Total Rewards Plan (eligible health/welfare, retirement/savings, work/life balance, career development) and employee benefits including medical/dental/vision, life/disability, flexible spending, bonus/incentive, stock-based long-term incentives, time-off, and flexible work models where possible.
Application Instructions
- Apply at careers.amgen.com. No application deadline; applications accepted until sufficient number received or candidate selected. Sponsorship not guaranteed.
What You Will Do
- Lead strategy, governance, transformation, and execution of continuous improvement initiatives across R&D Quality.
- Drive scalable, efficient, compliant, data-driven processes enhancing quality oversight across GCP, GLP, GVP, clinical development, pharmacovigilance, laboratories, quality systems, and external partnerships.
- Provide governance frameworks, strategic project management, and quality support for business development (acquisitions, due diligence, post-close integration).
- Partner with Quality leadership and cross-functional teams (R&D, Regulatory Affairs, IT, Finance, HR) to modernize operations and strengthen organizational performance.
Key Responsibilities
- Develop and execute a multi-year Operational Excellence roadmap aligned to R&D Quality strategy.
- Establish governance processes (operating reviews, planning cycles, decision forums, escalation).
- Drive R&D GxP quality governance models with escalation from L2 through L0.
- Lead annual goal setting, portfolio prioritization, budget tracking, and performance reviews.
- Lead/monitor cross-functional improvement initiatives across audits/inspections, quality systems, CAPA, supplier quality, and oversight models.
- Establish project management standards/tools; lead a portfolio ensuring scope, timelines, resources, risks, and deliverables.
- Represent R&D Quality in acquisition assessments, licensing, and strategic partnerships; lead quality due diligence and post-close integration.
- Establish KPIs for quality performance, efficiency, risk, and project delivery.
- Build capability through coaching, training, and mentoring.
Basic Qualifications
- Doctorate + 5 years in Quality Assurance/Strategy in a regulated industry OR Master’s + 9 years OR Bachelor’s + 11 years.
- At least 5 years managing people and/or leading teams/projects/programs or directing resource allocation.
Preferred Qualifications
- Strong GxP (GCP/GLP/PV) and quality system management knowledge.
- Enterprise transformation, governance, complex integration experience.
- Executive influence; advanced degree; Lean Six Sigma Black Belt/Master Black Belt.
- KPI/performance framework expertise; financial/business acumen/ROI.
- High EQ, strong communication; consulting with senior stakeholders.
- Experience integrating data science/AI/digital tools; thrives in ambiguity/matrixed global settings.
Benefits
- Total Rewards Plan (eligible health/welfare, retirement/savings, work/life balance, career development) and employee benefits including medical/dental/vision, life/disability, flexible spending, bonus/incentive, stock-based long-term incentives, time-off, and flexible work models where possible.
Application Instructions
- Apply at careers.amgen.com. No application deadline; applications accepted until sufficient number received or candidate selected. Sponsorship not guaranteed.