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 some of the world's most devastating diseases, including HIV, viral hepatitis, COVID-19, and cancer. The company's innovative therapies have delivered a cure for hepatitis C, revolutionary advancements in HIV treatment and prevention, and significant progress in oncology and inflammatory diseases. Headquartered in the United States, Gilead operates globally, with a strong commitment to accessibility and collaboration in addressing public health challenges.

At the La Verne, California facility, Gilead focuses on advanced manufacturing modalities, including pre-filled syringes, auto-injectors, and co-packaged kits for combination products. This site plays a pivotal role in the development and commercialization of life-changing therapies, upholding the highest standards of quality and regulatory compliance.

Role Overview

The Senior Manager, Quality Assurance - Medical Device & Combination Products position at Gilead Sciences in La Verne, California, is a critical leadership role supporting site manufacturing operations. This hands-on position ensures the highest quality standards for medical devices and combination products, with a strong emphasis on pre-filled syringes (PFS) manufacturing. The ideal candidate will bring expertise in ISO 13485, sterile drug product manufacturing, and device/container-closure systems, while leading cross-functional teams in a GMP-regulated environment.

This role offers an exciting opportunity to contribute to Gilead's bold ambitions in advancing new therapies for HIV, oncology, and inflammatory diseases. As a people leader, you will drive cultural evolution, fostering an inclusive environment where employees are empowered to innovate and excel.

Key Responsibilities

Leadership in Manufacturing Operations

Provide hands-on leadership for pre-filled syringe manufacturing, encompassing aseptic manufacturing, visual inspection, device assembly, and packaging. Your expertise will ensure seamless operations and adherence to best practices.

Regulatory Compliance and Expertise

Ensure site compliance with ISO 13485, FDA, EMA, and global regulations for drug-device combination products. Serve as the subject matter expert for PFS and medical device quality, including container-closure integrity, functional performance, and device-specific risk controls.

Cross-Functional Collaboration and Support

Support technology transfers, equipment qualifications, and validation activities. Collaborate with manufacturing, engineering, QC, supply chain, Regulatory Affairs, and Global Central QA to identify and mitigate quality risks proactively.

Monitoring and Improvement

Monitor updates to medical device QMS standards and industry regulatory trends, translating them into site-level improvements. Lead gap assessments, inspection readiness, audits, and regulatory inspections, while reviewing SOPs, protocols, and trend reports.

Complaints and Mentoring

Support the medical device and combination product complaints process, relaying findings to design teams. Provide functional leadership, mentoring Quality personnel, conducting training, and writing performance reviews.

Qualifications & Requirements

To succeed in this role, candidates must possess:

• Master’s degree in a Science or Engineering field with 6+ years of direct hands-on experience in medical device manufacturing, testing, or QA; or Bachelor’s degree with 8+ years of experience.
• Proven hands-on experience in medical device and combination product quality, including ISO 13485, sterile drug product manufacturing, and device/container-closure systems.
• Strong leadership experience in GMP-regulated environments, with expertise in aseptic processes, visual inspection, and packaging.
• Demonstrated ability to lead audits, inspections, and cross-functional initiatives.

Preference for candidates with experience in pre-filled syringes, auto-injectors, and regulatory trends in combination products.

Benefits & Perks

Gilead Sciences offers a comprehensive benefits package designed to support your well-being and professional success:

• Competitive salary estimated at $180,000 - $220,000 annually, based on biopharmaceutical sector rates in California with a 5-10% buffer.
• Robust health benefits including medical, dental, vision, and wellness programs.
• 401(k) with generous company match and financial planning resources.
• Paid time off, family leave, and flexible work options.
• Tuition reimbursement and ongoing professional development opportunities.

Career Growth

As a Senior Manager at Gilead, you will have access to unparalleled career advancement. Gilead invests heavily in leadership development, providing training programs, mentoring, and opportunities to lead high-impact projects. People leaders are central to evolving the company culture, ensuring every employee feels included and empowered. With Gilead's growth in HIV therapies, oncology, and inflammatory diseases, this role positions you for future executive opportunities in biopharma quality assurance.

Why Join Gilead

Joining Gilead means becoming part of a mission-driven team united against the world's biggest health challenges. Work on groundbreaking therapies that improve lives, from HIV prevention to cancer treatments. In La Verne, you'll contribute to cutting-edge combination product manufacturing, supported by a collaborative, innovative culture. Gilead values bold ambitions, determination, and direct impact—qualities that define our success.

Role FAQs

What is the primary focus of this role?

The role centers on quality assurance for medical devices and combination products, particularly pre-filled syringes at the La Verne site.

What qualifications are required?

A Master’s or Bachelor’s in Science/Engineering with substantial experience in medical device QA and GMP environments.

Is leadership experience necessary?

Yes, proven leadership in mentoring teams and managing quality functions is essential.

What benefits does Gilead offer?

Comprehensive health coverage, retirement plans, professional development, and a supportive culture.

How does this role contribute to Gilead's mission?

By ensuring regulatory compliance and quality in innovative therapies for HIV, oncology, and inflammatory diseases.