About Gilead Sciences

Gilead Sciences is a leading biopharmaceutical company dedicated to creating a healthier world for all people. For over 35 years, Gilead has pioneered breakthroughs in treating HIV, viral hepatitis, COVID-19, oncology, and inflammatory diseases. Our innovative therapies have transformed lives, from life-saving HIV treatments to cutting-edge oncology solutions and therapies for inflammatory conditions. Headquartered in Foster City, California, Gilead employs thousands of passionate professionals worldwide, collaborating to advance scientific discovery and ensure global access to vital medicines.

Our Mission and Impact

At Gilead, our mission drives relentless innovation against the world's biggest health challenges. We develop therapies that not only treat diseases but improve quality of life, with a strong focus on HIV management, oncology advancements, and inflammatory disease solutions. Our commitment to collaboration, determination, and bold ambitions positions us as a leader in biopharma.

Role Overview

The Sr Quality Engineer I role at Gilead Sciences in Foster City, California, is a pivotal position supporting the commercialization of groundbreaking combination products, such as pre-filled syringes and autoinjectors. As a key quality professional, you will collaborate with design and development teams during Design Transfer and provide end-to-end quality assurance for these innovative drug-device products. This full-time opportunity is ideal for experienced quality engineers passionate about ensuring compliance and driving continuous improvement in a fast-paced biopharma environment.

Key Responsibilities

In this role, you will play a critical part in Gilead's success by addressing complex quality challenges for combination products. Responsibilities include developing strong relationships with internal stakeholders and contract manufacturers to resolve technical issues related to drug-device combinations, processes, and quality. You will identify process gaps, lead cross-functional teams for solution implementation, and write or revise controlled documents like SOPs, specifications, and work instructions.

Quality Governance and Compliance

Ensure end-to-end quality support during Design Transfer and commercial stages by creating and executing SOPs. Execute changes to quality processes for conformance and improvement, maintaining strict adherence to FDA QSR/QMSR, ISO 13485, and ISO 14971 risk management standards. Work cross-functionally with R&D, Clinical, and Operations experts to apply comprehensive risk processes, participate in annual product reviews, and update Design History Files (DHF) and Risk Management Files (RMF).

Audits, Training, and Continuous Improvement

Review design inputs, outputs, verification/validation results, and analyze process data for capability and control. Stay ahead of evolving regulatory requirements, support due diligence, audits, and inspections. Provide quality training to stakeholders and CMOs, and assist in complaints investigations, feeding insights back to development teams.

Qualifications & Requirements

To succeed as Sr Quality Engineer I, candidates must have 6+ years of experience in the medical device industry with a Bachelor’s degree in a science or engineering-related field, or 4+ years with a Master’s degree. In-depth knowledge of quality principles, industry practices, and standards is essential, with preference for experience in combination devices like autoinjectors and pre-filled syringes, as well as Design Transfer to contract manufacturers.

Preferred Skills and Certifications

Previous quality experience in both clinical and commercial products is required, along with expertise in risk management methodologies such as Hazard Analysis or FMEA. Strong interpersonal skills, ability to work independently and in global teams, and understanding of U.S. and international regulations are key. Certifications from ASQ (Certified Quality Auditor, Certified Quality Engineer, or Certified Quality Manager) or similar are highly preferred. Maintain expertise in pharmaceuticals, medical devices, and combination products worldwide.

Benefits & Perks

Gilead Sciences offers a comprehensive benefits package designed to support your well-being and professional success. Enjoy competitive salaries estimated between $136,340 and $164,808 annually, performance incentives, and robust health coverage including medical, dental, and vision insurance. Our 401(k) plan features generous company matching, while tuition reimbursement and professional development programs fuel your growth. Additional perks include paid time off, wellness initiatives, and employee stock purchase plans, ensuring you thrive both personally and professionally.

Career Growth

Gilead invests in your future with opportunities for advancement in quality engineering, regulatory affairs, and leadership roles. As a people leader or aspiring one, you'll drive cultural evolution, fostering inclusion and empowerment. Access mentorship, training, and global projects that align with our bold ambitions in HIV, oncology, and inflammatory diseases.

Why Join Gilead

Joining Gilead means contributing to life-changing innovations in HIV treatments, oncology breakthroughs, and inflammatory disease therapies. Work in Foster City, California, at the heart of biopharma innovation, with a collaborative culture that values every employee's impact. Be part of a team relentless in pursuit of a healthier world, with resources to achieve your aspirations.

Role FAQs

Q: What experience is required? A: 6+ years in medical devices with a Bachelor’s or 4+ with a Master’s, plus combination product knowledge.

Q: Is relocation assistance available? A: Gilead supports talent acquisition; inquire during application.

Q: What standards must I ensure compliance with? A: FDA QSR, ISO 13485, ISO 14971, and global regulations.

Q: How does this role support Gilead's mission? A: By ensuring quality in combo products for HIV, oncology, and more.

Q: What's the work environment like? A: Collaborative, global teams with cross-functional interaction.