Sr Manager, Quality, Development Packaging

职位描述

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.