Job Description
Job Overview:
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
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.
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.
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.
Preferred Qualifications
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.
People Leader Accountabilities
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
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.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
