Senior Director, Operational Excellence

Amgen • Thousand Oaks, CA

1d • $199,782 - $270,294

About The Position

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. Senior Director, Operational Excellence What you will do Let’s do this! Let’s change the world! The Senior Director of Operational Excellence will lead the strategy, governance, transformation, and execution of continuous improvement initiatives across the Research & Development (R&D) Quality organization. This leader will drive scalable, efficient, compliant, and data-driven processes that enhance quality oversight across GCP, GLP, GVP and research functions including clinical development, pharmacovigilance, laboratories, quality systems, and external partnerships. This role will also lead governance frameworks, strategic project management, and Quality support for business development activities including acquisitions, due diligence, and post-close integration. The position partners closely with Quality leadership, R&D functions, Regulatory Affairs, IT, Finance, HR, and external partners to modernize operations and strengthen organizational performance

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
• At least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
• 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.

Responsibilities

• 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 (“looking around corners”).
• Navigate ambiguity with confidence and agility, aligning teams and stakeholders around a common transformation vision

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree