Sr Manager, Quality, Development Packaging

Gilead Sciences • Foster City, CA

1d

About The Position

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Sr. Manager, Quality, Development Packaging at Gilead you will provide quality review and ensure compliant execution of packaging development activities.

Requirements

• Bachelor’s degree in engineering or a scientific discipline with 8+ years of relevant experience OR Master’s degree with 6+ years of relevant experience OR PhD with 2+ years of relevant experience
• Demonstrated experience in quality assurance for medical device and/or drug–device combination product development.
• Demonstrated experience in quality assurance for pharmaceutical secondary packaging development.
• Proven experience with packaging validation and performance testing (e.g., transit, drop testing).
• Strong foundation in statistical methods (normality tests, capability analysis, tolerance intervals), test method validation (MSA, Gage R&R), and risk management per ISO 14971 (including FMEA and systems analysis). Expertise in at least one of these areas is required.
• Ability to develop, interpret, and improve complex concepts, standards, and applications based on quality principles.
• Excellent verbal, written, and interpersonal communication skills.

Nice To Haves

• Experience with combination products such as auto injectors, co‑packaged kits, and pre-filled syringes.
• Strong understanding of medical devices, combination products, and/or secondary packaging manufacturing processes.
• Strong project management and process improvement capabilities.
• Knowledge of domestic and international quality system regulations and demonstrated ability to drive continuous improvement.

Responsibilities

• Quality Oversight of Packaging Development
• Provide quality review and approval of packaging development documentation, including protocols, reports, risk assessments, specifications, and test methods.
• Ensure packaging components and systems meet applicable regulatory requirements (FDA, EMA, ICH) and comply with Gilead’s Quality System and cGMP principles.
• Assess packaging designs and qualifications for adherence to relevant industry standards (e.g., USP, ASTM, ISO) and internal quality expectations.
• Design Control & Risk Management Support design control activities for packaging systems and combination product configurations, ensuring proper documentation, traceability, and risk management.
• Lead or contribute to risk assessments (e.g., FMEA, hazard analysis) for packaging components, processes, and container closure systems.
• Packaging Qualification & Compliance Ensure that shipping studies, human factors, and component qualifications, and compatibility assessments are executed in a compliant and scientifically sound manner.
• Support review of data and justification for packaging material selection, CCS integrity, and performance testing.
• Regulatory & Documentation Support Contribute to regulatory submissions by reviewing packaging‑related quality documentation and ensuring accuracy, traceability, and regulatory alignment.
• Review, maintain, and/or author quality procedures (SOPs) associated with packaging development and qualification activities.
• Cross‑Functional Collaboration Serve as a key Quality partner to internal and external stakeholders to ensure packaging development activities are executed in compliance with quality and regulatory requirements.
• Provide quality guidance during technical discussions and support continuous improvement initiatives related to packaging systems and combination products.

Benefits

• 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, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level