Director, Operational Excellence - Internal Quality

Job Description

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.

Decision Scope, Discretion & Accountability

• Owns Internal Quality Operational Excellence vision, strategy, and operating model across QA and QC

• Sets portfolio priorities and aligns OE initiatives to Quality and enterprise objectives

• Exercises broad autonomy in determining objectives, approaches, and sequencing of work across multiple sites

• Serves as the escalation point for delivery risks, prioritization conflicts, and benefit realization challenges

• Establishes governance, performance expectations, and controls to ensure sustained results

Portfolio Governance & Benefits Realization

• Owns Internal Quality OE portfolio, including prioritization, benefits tracking, and value realization

• Defines and enforces standard OE governance, cadence, metrics, and reporting across initiatives

• Ensures transparency, rigor, and disciplined execution across the OE portfolio

• Partners with senior leaders to validate investment cases and realized benefits

Network Enablement & Capability Building

• Builds and sustains an Internal Quality Operational Excellence network across sites

• Defines and standardizes OE methodologies, standards, tools, and templates

• Develops OE capability through coaching, mentoring, and community‑of‑practice leadership

• Drives cross‑site harmonization and sharing of best practices and lessons learned

Span of Control

• Direct people leadership responsibility for Operational Excellence leads and specialists

• Leads and influences matrixed teams across sites and functions

• Accountable for performance management, talent development, and succession planning

Key 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

Knowledge:

• 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.

Specific Job Responsibilities:

• 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.

Basic Qualifications:

Bachelor's Degree and Twelve Years’ Experience

OR

Masters' Degree and Ten Years’ Experience

OR

PhD and Eight Years’ Experience

Preferred Qualifications:

• 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.

People Leader Accountabilities

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.