Director, Operational Excellence - Internal Quality
About The Position
The Director, Operational Excellence – Internal Quality is a people leader who owns the vision, strategy, and operating model for Operational Excellence across Internal Quality. This role ensures strong strategy‑to‑execution alignment, delivering sustained improvements in compliance, efficiency, cycle time, cost, and right‑first‑time outcomes across Quality Assurance and Quality Control while maintaining inspection readiness and patient safety in a GxP environment. The role serves as the enterprise Operational Excellence leader for Internal Quality, aligning priorities to Quality and enterprise strategy, governing delivery, enabling the OE network, and ensuring measurable value realization across a portfolio of initiatives. This role will sit in Foster City, CA.
Requirements
- Demonstrates in-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.
- Demonstrates substantial knowledge of industry best practices and trends.
- Is comfortable interacting with regulatory agencies as needed and possess the ability to represent Gilead in public forums
- Demonstrates excellent verbal, written, and interpersonal communication skills.
- Bachelor's Degree and Twelve Years’ Experience OR Masters' Degree and Ten Years’ Experience OR PhD and Eight Years’ Experience
- 10+ years of relevant experience in the pharmaceutical industry and a BS or BA.
- Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment.
- Prior people management experience.
Responsibilities
- Define and execute the Internal Quality Operational Excellence strategy and multi-year roadmap
- Lead a portfolio of complex, multi-site QA and QC transformation initiatives
- Establish Operational Excellence governance including prioritization, KPIs, benefits tracking, and sustainment
- Enable data‑driven decision making through performance metrics and insights
- Develop organizational capability in Lean, Six Sigma, and change leadership
- Partner with Quality Systems, Lab Ops, Manufacturing, and Digital on end-to-end performance
- Integrate Quality Risk Management into improvement design and execution
- Serve as a trusted advisor to senior Quality leadership
- Model inclusive leadership and a culture of continuous improvement
- Manages personnel, including organizing and prioritizing group tasks, performing training, writing performance reviews and guiding personnel in longer-term development.
- Performs a wide variety of activities to ensure compliance applicable regulatory requirements, to facilitate compliance with regulatory agencies, customer and MA holder requirements.
- Develops, implements, and maintains systems, programs and processes to ensure compliance with Current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs), along with compliance of protocols, GMPs and safety regulations.
- Creates, implements, and qualifies current and new programs, policies, processes, procedures and controls to ensure that performance and quality of products conform to established standards and agency guidelines.
- Reviews and approves training programs regarding implementation of quality systems.
- Interfaces with regulatory agencies as required, representing Gilead to authorities and regulatory inspectorate bodies as required.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
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What This Job Offers
Job Type
Full-time
Career Level
Director
