About Gilead Sciences

Gilead Sciences is a biopharmaceutical leader dedicated to creating a healthier world for all people. For over 35 years, Gilead has tackled some of the world's most pressing health challenges, including HIV, viral hepatitis, COVID-19, and cancer. The company has achieved groundbreaking milestones, such as a cure for hepatitis C, revolutionary advancements in HIV treatment and prevention, and innovative therapies for viral, inflammatory diseases, and certain cancers. Headquartered in the United States, Gilead operates globally, ensuring access to life-changing medicines. With a commitment to collaboration, determination, and bold ambitions, Gilead's employees drive scientific innovations that improve patient lives across generations. Join a team united in confronting public health crises and advancing therapies in HIV, oncology, and inflammatory diseases.

Role Overview

The Director, External Quality Strategy and Operations role at Gilead Sciences is a senior leadership position within the Pharmaceutical Development and Manufacturing (PDM) External Quality team. This role involves leading a team of quality professionals to develop and implement standardized communication, training, and rollout of Gilead’s quality standards, requirements, systems, and tools across the global contract organization network. Reporting to PDM External Quality leadership, the Director will drive strategic initiatives that enhance operational excellence, ensure compliance with cGMP standards, and support Gilead's mission in delivering high-quality therapies for HIV, oncology, and inflammatory diseases. This is an ideal opportunity for seasoned quality leaders passionate about process optimization and cross-functional collaboration in a dynamic biopharmaceutical environment.

Strategic Impact

In this role, you will evaluate options, manage trade-offs, and partner with Global Quality and PDM leaders to achieve business objectives. Your expertise will directly influence Gilead's ability to maintain rigorous quality standards with external partners, ensuring the safety and efficacy of therapies reaching patients worldwide.

Key Responsibilities

As Director, External Quality Strategy and Operations, your core duties include:

• Leading cross-functional business and quality process mapping, leveraging exceptional facilitation skills to gather SME input and design practical, end-to-end processes that drive meaningful improvements.
• Managing quality agreements, coordinating quarterly management review metrics collection, and overseeing annual product quality reviews.
• Defining and aligning requirements and processes for contract organizations’ quality event management, including deviations, investigations, corrective and preventative actions (CAPA), and change control.
• Successfully rolling out Gilead’s Partner Collaboration Quality System module to the global contract organization network consistently.
• Serving as a key representative for Gilead’s Quality Transformation initiatives, utilizing business process management tools strategically.

Leadership and Collaboration

You will lead Operational Excellence (OpEx) initiatives spanning multiple PDM External Quality teams, fostering a culture of continuous improvement and compliance.

Qualifications & Requirements

To succeed in this role, candidates must demonstrate:

• Proven track record in leading Operational Excellence in a Quality organization within a biotech or pharmaceutical development environment.
• Strong knowledge of cGMP quality systems and expertise in quality event management.
• Exceptional skills in cross-functional process mapping, OpEx initiatives, and business process management tools.
• Experience in managing quality agreements, metrics collection, and system rollouts to global networks.
• Ability to partner with senior leaders, evaluate trade-offs, and drive positive business impact.

A bachelor's degree in a relevant scientific discipline is required, with advanced degrees or certifications in quality management preferred. Minimum 12-15 years of experience in pharmaceutical quality operations, with at least 5 years in leadership roles.

Benefits & Perks

Gilead Sciences offers a comprehensive benefits package designed to support your well-being and professional growth:

• Competitive base salary with performance-based bonuses and equity opportunities.
• Robust health insurance, including medical, dental, and vision coverage, plus wellness programs.
• Generous 401(k) matching, tuition reimbursement, and paid parental leave.
• Flexible work arrangements, employee stock purchase plans, and onsite fitness facilities.
• Extensive learning and development resources, including leadership training for people managers.

Career Growth

At Gilead, people leaders are pivotal to the employee experience. This Director role positions you for further advancement into executive quality leadership or broader PDM operations. Benefit from mentorship, cross-functional projects, and exposure to Gilead's global initiatives in HIV, oncology, and inflammatory diseases. Gilead invests in your growth, empowering you to evolve the culture and develop inclusive teams.

Why Join Gilead

Joining Gilead means contributing to bold ambitions against devastating diseases. Work on therapies that have transformed HIV care, cured hepatitis C, and advanced oncology and inflammatory treatments. Enjoy a collaborative environment where every employee feels included, developed, and empowered. Gilead's commitment to innovation and patient access makes it a premier employer in biopharma. Help create possible, together.

Role FAQs

Q: What level of experience is required?
A: Candidates need proven leadership in OpEx and cGMP in biotech/pharma, typically 12+ years total experience.

Q: Is travel required?
A: Yes, occasional global travel to contract organizations may be necessary.

Q: What tools are used?
A: Expertise in business process management tools, Partner Collaboration Quality System, and OpEx methodologies.

Q: How does this role impact patients?
A: By ensuring quality standards for external manufacturing, you safeguard therapies for HIV, cancer, and more.

Q: What is the team structure?
A: Lead a team of quality professionals, collaborating cross-functionally with PDM and Global Quality.