Director, Operational Excellence - Internal Quality

职位描述

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

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.

The salary range for this position is: $210,375.00 - $272,250.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.