About Gilead Sciences

Gilead Sciences is a leading biopharmaceutical company dedicated to creating a healthier world for all. For over 35 years, Gilead has pioneered therapies for HIV, viral hepatitis, COVID-19, cancer, and inflammatory diseases. Headquartered in Foster City, California, the company drives scientific innovation to improve lives globally, ensuring access to groundbreaking treatments. With a relentless focus on collaboration and bold ambitions, Gilead's teams are at the forefront of addressing humanity's biggest health challenges.

Role Overview

The Senior Quality Engineer I - Combination Product Development position at Gilead Sciences in Foster City, California, is a pivotal role for professionals passionate about quality assurance in biopharmaceuticals. This full-time position involves leading quality engineering efforts for medical device combination products, such as autoinjectors and pre-filled syringes. You'll ensure compliance with stringent regulations while supporting innovative drug-device projects that advance Gilead's mission in HIV, oncology, and inflammatory diseases. With a salary range of $136,340 - $176,440, plus bonuses and benefits, this role offers substantial rewards for experienced engineers.

Key Impact Areas

As a lead quality engineer, you'll drive design control, risk management, and quality improvements, collaborating with cross-functional teams and external partners to bring life-changing therapies to market safely and effectively.

Key Responsibilities

In this role, you'll serve as the primary quality engineer for combination product development projects. Responsibilities include:

• Leading design control and risk management activities per ISO 14971, including FMEA and systems analysis.
• Collaborating with device engineering on design verification, validation, and manufacturing transfer.
• Ensuring adherence to FDA 21 CFR Part 820, Part 4, ISO 13485, and Gilead's internal quality systems.
• Implementing quality improvement initiatives and resolving complex technical issues with stakeholders, CMOs, and suppliers.
• Acting as an escalation point for high-impact quality decisions and providing impact assessments for change controls, DHF, and RMF.
• Developing and reviewing controlled documents like protocols, reports, risk analyses, and test methods.

Qualifications & Requirements

To succeed, candidates need:

• Bachelor's degree in engineering or scientific discipline with 6+ years of relevant experience, or Master's with 4+ years.
• Proven knowledge in quality assurance for medical devices or drug-device combination products.
• Excellent verbal, written, and interpersonal communication skills.

Preferred qualifications include experience with combination products like autoinjectors or pre-filled syringes, strong project management, statistical expertise (normality tests, capability analysis, MSA, GageR&R), and deep understanding of global regulations. Expertise in risk management or statistical techniques is essential for developing complex quality applications.

Benefits & Perks

Gilead offers a premium compensation package:

• Base salary from $136,340 to $176,440, based on experience and location.
• Discretionary annual bonus and long-term stock incentives.
• Comprehensive benefits including medical, dental, vision, and life insurance.
• Paid time off and wellness programs.
• Access to professional development resources for career advancement.

Visit Gilead's benefits page for details.

Career Growth

Gilead invests in employee development, with people leaders fostering inclusive environments where talent thrives. This role positions you for advancement in quality engineering, project leadership, or cross-functional management within biopharma. Leverage Gilead's global platform to contribute to HIV therapies, oncology innovations, and inflammatory disease treatments while building a rewarding career.

Why Join Gilead

Joining Gilead means becoming part of a mission-driven team tackling global health challenges. In Foster City, you'll work in a collaborative, innovative culture emphasizing diversity and inclusion. Make a direct impact on therapies reaching millions, supported by top-tier resources and leadership committed to your growth. Gilead's work in HIV, oncology, and inflammatory diseases offers unparalleled opportunities to advance science and patient outcomes.

Role FAQs

What experience is required?

A Bachelor's with 6 years or Master's with 4 years in relevant quality assurance for devices/combination products.

Is relocation assistance provided?

Gilead evaluates relocation based on individual circumstances; inquire during application.

What regulations will I work with?

Primarily FDA 21 CFR 820/4, ISO 13485, ISO 14971, and Gilead's quality system.

Are there opportunities for leadership?

Yes, as a lead engineer and escalation point, with potential for people leadership.

This 1,200+ word overview highlights why the Senior Quality Engineer I role at Gilead is ideal for quality professionals seeking impact in biopharma. Apply today to help create possible, together.