Manager, Quality Systems

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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
 

Manager, Quality Systems

Responsibilities:

• Supports, facilitates, and adapts the Gilead Quality Management System for equipment, utilities, facilities, processes, and/or automation systems to ensure that it meets regulatory and industry standards and expectations.

• Provide quality oversight for commissioning, qualification, and validation activities for GxP pilot plants and GMP warehouse equipment, utilities, and automation systems.

• Work closely with the Business Process Owners, Facilities, Validation, and Engineering teams to ensure that GxP systems are deployed according to company standards and relevant regulations and maintained in a validated state.

• Reviews and approves validation deliverables for medium-to-large-sized projects.

• Provide technical and quality qualification assessment and approval for engineering and process changes.

• Review and approve Pilot Plant’s GMP Drawings

• Review and approve Asset Induction, Unscheduled work orders, and environmental monitoring records.

• Review and approve procedures, work instructions, and other governing documents to support Gilead’s GxP systems.

• Provide oversight and QA approvals for GxP Deviations, CAPAs, and change controls to ensure activities comply with Gilead procedures and regulatory requirements.

• Provide expert guidance on commissioning and validation activities on equipment, utilities (e.g., HVAC, Nitrogen, Water Systems), and automation systems (Siemens BMS, EBR, GxP PI Historian, Process Control Systems).

• Maintains programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (GMPs).

• Interface with regulatory agencies as required.

• Performs various activities to ensure compliance with quality systems, quality procedures, and applicable regulatory requirements.

• Manages QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.

• Participate in developing training programs regarding all aspects of quality systems administration.

• Participates in compliance audits as required.

Knowledge and Skills:

• Demonstrates proficiency in regulatory requirements pertaining to equipment, utilities, facilities, and automation systems commissioning/validation in GxP environments.

• Demonstrates proficiency in understanding and ap