Senior Director, Operational Excellence

Role Overview

• Lead the strategy, governance, transformation, and execution of continuous improvement initiatives across the Research & Development (R&D) Quality organization
• Drive scalable, efficient, compliant, and data-driven processes that enhance quality oversight across GCP, GLP, GVP and research functions
• Lead governance frameworks, strategic project management, and Quality support for business development activities
• 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
• 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”).

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.

Tech Stack

• Google Cloud Platform

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.