Job Abstract

The Senior Quality Engineer will play a critical role in ensuring the quality and compliance of our combination products throughout the product development lifecycle. This individual will collaborate with cross-functional teams, providing expertise in design control, risk management, and regulatory compliance to ensure the successful delivery of safe and effective combination products. Roles/ Responsibilities:Design Control:Provide QA oversight for all stages of the Design Control process accord... more details

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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.We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.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. Join Gilead and help create possible, together.

Senior Quality Engineer  – Combination Product Development

The Senior Quality Engineer will play a critical role in ensuring the quality and compliance of our combination products throughout the product development lifecycle. This individual will collaborate with cross-functional teams, providing expertise in design control, risk management, and regulatory compliance to ensure the successful delivery of safe and effective combination products.

Roles/Responsibilities:

• Design Control:

  • Provide QA oversight for all stages of the Design Control process according to FDA 21 CFR Part 820.30, ISO 13485, other applicable regulations, and Gilead quality system requirements.

  • Lead/support the determination and implementation of Design Controls based on Risk Management, User Needs, and Manufacturing Input.

  • Mentor cross functional team through product life cycle process; specifically, with respect to design control and risk management deliverables.

  • Write and/or implement changes to controlled documents (e.g., SOPs, specifications, test methods, etc.).

  • Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.

• Risk Management:

  • Provide risk management guidance to product development teams and support implementation of risk management strategies and associated documentation (Hazard Analysis, Fault Tree, FMEAs).

  • Provide guidance and impact assessments for Change Control, including DHF/RMF assessments.

• Quality Systems and Compliance:

  • Perform a wide variety of Quality Engineering activities to ensure compliance with applicable quality objectives and regulatory requirements.

  • Implement and maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs) and regulations.

  • Support internal and regulatory combination product audits both within Gilead and at CMOs.

  • Collaborate with regulatory affairs to prepare and support submissions to regulatory authorities.

  • May interface with regulatory agencies as required.

Knowledge, Experience, and Skills:

• Minimum of a Master’s degree in Biomedical Engineering, Mechanical Engineering or related field of study and 4+ years of relevant experience; or Bachelor's degree and 6+ years of relevant experience.

• Previous experience with combination products is preferred, such as autoinjectors, co-packed kits, pre-filled syringes.

• Ability to manage multiple priorities and work with ambiguity.

• Knowledge of applicable regulations/standards, such as 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC 62366, Part 4, etc. with a focus on Design Controls and Risk Analysis

• Certification by ASQ (CQE or CSSBB) or is preferred.

 

The salary range for this position is: $133,280.00 - $172,480.00. 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.

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 ApplicantAccommodations@gilead.com for assistance.
 

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