Quality Assurance Specialist - Laboratory Systems

Quality Assurance Manager

Capture and manage Quality Systems enhancements and integrations to various platforms and ensure timely and effective implementation. Provide expert Quality Assurance ("QA") guidance on topics related to system compliance to regulatory requirements. Create, organize, and maintain comprehensive QA project documentation and reporting. Incorporate and coordinate Organizational Change Management strategies, as appropriate. Manage the relationships with all internal and external stakeholders throughout project life cycle. Measure QA project performance using appropriate systems, tools, and techniques. Perform and assess risk management to minimize project risks and escalate project risks to management when needed. Monitor overall project portfolios within QA (e.g. Quality Engineering, Quality Center of Operational Excellence, Quality Policies and Systems) to review improvement ideas, track progress, and communicate project outcomes across the network. Identify opportunities for, and lead implementation of projects that drive the continued improvement of Gilead's quality management processes. Guide junior QA staff, fostering a culture of quality excellence, accountability, and continuous improvement. Ensure that technical, business and QA teams are prepared for regulatory inspections. Stay current with industry trends, regulatory changes, and best practices in quality assurance systems to proactively apply knowledge to manage QA processes and systems. Provide oversight and QA approvals for good practice (GxP) Deviations, Corrective and Prevention Actions (CAPAs) and change controls to ensure activities are conducted in compliance with Gilead procedures and regulatory requirements. Provide QA Reviews / approves procedures, work instructions and other governing documents. Learn, interpret and review computer systems protocols. May telecommute to New Hope, PA from any U.S. location.

Requirements : Master's degree in information technology, computer science, engineering or a related field, plus 3 years of experience, or in alternative, bachelor's degree in information technology, computer science, engineering or a related field, plus 5 years of post-bachelor experience. Experience must include the following : FDA regulations including Good Manufacturing Practices, Quality systems principles, concepts, industry practices and standards, and Document and Quality Management System (e.g., Veeva Vault, Trackwise). Skills and other requirements need not extend over the full length of required experience.