Sr. Quality Engineer – Combination Products, External Quality Engineering

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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 Sr. Quality Engineer – Combination Products, External Quality Engineering will play a key role in overseeing Gilead’s external CXO’s, including Contract Manufacturing Organizations (CMOs), Contract Test Labs, and Service Providers, supporting combination product development and manufacturing. This role ensures compliance with regulatory and company standards, manages supplier relationships, and drives quality oversight. The position acts as the vendor site owner and quality lead for assigned suppliers, partnering with cross-functional teams to achieve operational excellence.

Key Responsibilities:

• Serve as the Quality lead and vendor site owner for assigned suppliers, ensuring alignment with Gilead quality standards and regulatory requirements.

• Participate in supplier audits and lead risk assessments, and periodic reviews as part of supplier qualification and ongoing oversight activities.

• Develop, negotiate, and manage Quality Agreements with CMOs, Contract Test Labs, and Service Providers to define roles, responsibilities, and compliance expectations.

• Maintain comprehensive supplier records, including compliance history, performance metrics, and audit findings, to support risk management and strategic decision-making.

• Collaborate with CXO teams, project teams, Supplier Quality Management (SQM) for materials, and Strategic Sourcing to integrate supplier management into broader business strategies.

• Facilitate cross-functional efforts to resolve CXO-related quality issues, conduct root cause analyses, and implement corrective and preventive actions (CAPAs).

• Monitor and evaluate supplier performance through scorecards, trend analysis, and supplier reviews, driving continuous improvement initiatives.

• Ensure compliance with applicable global regulations, including ISO 13485, FDA 21 CFR Part 4/Part 820, and other relevant combination product standards, while adhering to internal quality policies.

Knowledge, Experience & Skills:

• Must have 6+ years of experience in the medical device industry and a Bachelor’s degree in science or engineering related field, or equivalent OR 4+ years of relevant experience with a Master’s degree.

• Demonstrates in-depth knowledge of Quality principles, concepts, industry practices, and standards.

• Previous experience with Material Qualification, PPAP and qualification preferred. 

• Previous experience with combination devices is preferred (i.e., Autoinjectors, co-packaged kits, pre-filled syringes) and/or previous experience managing Drug or Device CXO’s.

• Quality experience in both clinical and commercial products.

• Strong project management and process improvement skills.

• Demonstrates understanding of U.S. and international quality systems regulations/standards to adopt best in class systems/processes and drive continuous improvement initiatives.

• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is preferred.

• Knowledge of ISO 14971 Risk Management tools (e.g., Hazard Analysis / or Failure Mode Effects Analysis (FMEA)) is preferred.

• Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is preferred.

The salary range for this position is: $136,340.00 - $176,440.00. 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.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 [email protected] for assistance.
 

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.