Sr Quality Engineer Combination Products External Quality Engineering
Sr Quality Engineer Combination Products External Quality Engineering
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$ 136340 - 176440
1 Vacancy
Job Description
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of lifechanging scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were 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
TheSr. Quality Engineer Combination Products External Quality Engineeringwill play a key role in overseeing Gileads external CXOs 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 crossfunctional 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 decisionmaking.
Collaborate with CXO teams project teams Supplier Quality Management (SQM) for materials and Strategic Sourcing to integrate supplier management into broader business strategies.
Facilitate crossfunctional efforts to resolve CXOrelated 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 Bachelors degree in science or engineering related field or equivalent OR 4 years of relevant experience with a Masters degree.
Demonstrates indepth 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 copackaged kits prefilled syringes) and/or previous experience managing Drug or Device CXOs.
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 DefineMeasureAnalyzeImproveControl (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 industryrecognized professional organizations is preferred.
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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 disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob 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 for assistance.
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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 log onto your Internal Career Site to apply for this job.
Required Experience:
Senior IC
Employment Type
Full-Time
