Gilead Sciences, Inc.
Sr. Quality Engineer – Combination Products, External Quality Engineering
Gilead Sciences, Inc., San Mateo, California, United States, 94404
Sr. Quality Engineer – Combination Products, External Quality EngineeringJob 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.
Find out if this opportunity is a good fit by reading all of the information that follows below. 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: Gilead Benefits
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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.
Find out if this opportunity is a good fit by reading all of the information that follows below. 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: Gilead Benefits
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