Assoc Director, MDCP Quality Assurance

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.
 

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.
 

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 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

 

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, vi