GILEAD
At Gilead, were creating a healthier world for all people. For more than 35 years, weve 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 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 life-changing 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
Job Responsibilities: Process Development & Standardization:Design and refine the quality processes that support our combination product development lifecycle, with a focus ondeveloping and implementing standardized work and best practices to be applied consistently across all MDCP programs.Champion initiatives to improve the systems governing design controls, change control, and documentation.
Interface & Boundary Definition:Architect the operational interfaces and delineate clear system boundaries between key internal partner functions(e.g., Drug Product, Packaging, Device Engineering, etc). Establish formal processes for hand-offs and define ownership to ensure seamless integration in the development cycle.
Project Leadership & Execution:Serve as the lead Quality Engineer on critical development projects, providing hands-on guidance to teams for design verification, validation, and design transfer activities. You will be the central quality expert ensuring project milestones are met in a compliant manner.
Cross-Functional Collaboration:Establish and model effective engagement pathways between Quality, Device Engineering, Regulatory, and internal and external partners (CMOs, suppliers).
Compliance & Documentation:Ensure all project-level work (DHF, RMF, protocols, reports) is in full compliance with global regulations and standards (FDA 21 CFR Part 820/Part 4, ISO 13485). Contribute to the standardization of these controlled documents for broader use.
Basic Qualifications: Bachelor's degree in engineering or a scientific discipline with 10+ years of relevant experience, OR a Master's degree in a relevant field with 8+ years of relevant experience.
Demonstrated knowledge and experience in quality assurance for the development of medical devices and/or drug-device combination products.
Preferred Qualifications: Prior experience with combination products (e.g., autoinjectors, co-packed kits, pre-filled syringes) is preferred.
Strong project management and process improvement skills.
Understanding of domestic and international quality system regulations and the ability to drive continuous improvement.
Possess a strong foundation in statistical techniques (e.g., normality tests, capability analysis, tolerance intervals), test method validation (MSA, Gage R&R), and risk management principles per ISO 14971, including FMEA and systems analysis. Expertise in one of these areas is required
Ability to develop and improve complex concepts, techniques, standards, and new applications based on quality principles and theories.
Strong knowledge of medical devices and or combination products manufacturing.
Excellent verbal, written, and interpersonal communication skills
The salary range for this position is: $182,070.00 - $235,620.00. 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. For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , 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.
For more information about equal employment opportunity protections, please view the 'Know 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 apply via the Internal Career Opportunities portal in Workday. #J-18808-Ljbffr
Every member of Gileads 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 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
Job Responsibilities: Process Development & Standardization:Design and refine the quality processes that support our combination product development lifecycle, with a focus ondeveloping and implementing standardized work and best practices to be applied consistently across all MDCP programs.Champion initiatives to improve the systems governing design controls, change control, and documentation.
Interface & Boundary Definition:Architect the operational interfaces and delineate clear system boundaries between key internal partner functions(e.g., Drug Product, Packaging, Device Engineering, etc). Establish formal processes for hand-offs and define ownership to ensure seamless integration in the development cycle.
Project Leadership & Execution:Serve as the lead Quality Engineer on critical development projects, providing hands-on guidance to teams for design verification, validation, and design transfer activities. You will be the central quality expert ensuring project milestones are met in a compliant manner.
Cross-Functional Collaboration:Establish and model effective engagement pathways between Quality, Device Engineering, Regulatory, and internal and external partners (CMOs, suppliers).
Compliance & Documentation:Ensure all project-level work (DHF, RMF, protocols, reports) is in full compliance with global regulations and standards (FDA 21 CFR Part 820/Part 4, ISO 13485). Contribute to the standardization of these controlled documents for broader use.
Basic Qualifications: Bachelor's degree in engineering or a scientific discipline with 10+ years of relevant experience, OR a Master's degree in a relevant field with 8+ years of relevant experience.
Demonstrated knowledge and experience in quality assurance for the development of medical devices and/or drug-device combination products.
Preferred Qualifications: Prior experience with combination products (e.g., autoinjectors, co-packed kits, pre-filled syringes) is preferred.
Strong project management and process improvement skills.
Understanding of domestic and international quality system regulations and the ability to drive continuous improvement.
Possess a strong foundation in statistical techniques (e.g., normality tests, capability analysis, tolerance intervals), test method validation (MSA, Gage R&R), and risk management principles per ISO 14971, including FMEA and systems analysis. Expertise in one of these areas is required
Ability to develop and improve complex concepts, techniques, standards, and new applications based on quality principles and theories.
Strong knowledge of medical devices and or combination products manufacturing.
Excellent verbal, written, and interpersonal communication skills
The salary range for this position is: $182,070.00 - $235,620.00. 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. For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , 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.
For more information about equal employment opportunity protections, please view the 'Know 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 apply via the Internal Career Opportunities portal in Workday. #J-18808-Ljbffr