Gilead Sciences, Inc.
Assoc Director, MDCP Quality Assurance
Gilead Sciences, Inc., Foster City, California, United States, 94420
Process Development & Standardization: Design and refine the quality processes that support our combination product development lifecycle, with a focus on developing 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.
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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.
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