Sr. Quality Assurance Specialist

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 Position SummaryGilead Sciences is seeking a highly motivated and experienced Sr. Quality Assurance Specialist to join the Corporate Engineering and Facilities (CEF) team in Foster City, CA. This role is responsible for providing quality oversight and hands-on ownership, authoring, and execution for GxP quality records associated with CEF activities including facilities, utilities, equipment, instruments, and engineering systems.The Sr. Quality Assurance Specialist is responsible for ensuring compliance with applicable quality objectives, regulatory requirements, and current Good Manufacturing Practices (cGMP), and serves as the primary owner for applicable deviation investigations, corrective and preventive actions (CAPAs), effectiveness checks, and related change controls. This role ensures records are complete, accurate, and inspection-ready and supports appropriate lifecycle management of impacted systems and activities.The ideal candidate will possess a strong understanding of biotech/pharmaceutical mission‑critical facility environments and GxP utility infrastructure, such as HVAC, BMS/EMS, RO/DI and WFI water, CDA, nitrogen, and automated building systems. This role partners closely with Facilities Operations, Technical Engineering, Project Management, EHS, Calibration/Preventive Maintenance, Automation, Validation, vendors, and Quality Assurance to ensure engineering, maintenance, calibration, qualification, and change activities are executed in alignment with regulatory requirements and internal quality standards.Key ResponsibilitiesQuality System Records (Core Scope)Independently conduct, document, and close critical, major, and minor investigations related to facilities, utilities, equipment, instrumentation, calibration, maintenance, and engineering systems.Act as the Deviation Investigation Owner for Facilities and Engineering quality records.Manage and track Deviation Reports, ensuring timely root cause analysis, impact assessments, and adherence to established due dates.Lead, assess, approve, and verify Corrective and Preventive Actions (CAPAs) and associated Effectiveness Checks.Coordinate with Quality Assurance to ensure appropriate review, approval, and closure of quality records.Initiate, author, and support Change Control Records associated with:Facility modifications and utility system changesEquipment and instrument installation or removalBMS/EMS configuration and firmware updatesCMMS asset updates and engineering system integrationsMaintain and update quality tracking tools and databases; issue reminders and monitor performance against targets.Develop, analyze, and present quality system metrics and trending reports for management review; escalate risks and issues as appropriate.Demonstrated technical writing experience in biotech or pharmaceutical environments.Proven technical literacy sufficient to understand facilities, utilities, MEP, and automation systems in support of GxP quality records.Investigation Leadership & Technical Problem SolvingFacilitate cross‑functional meetings with Facilities Operations, Engineering, EHS, Calibration/PM, Automation, Validation, and external vendors to align on investigations and corrective actions.Apply structured Root Cause Analysis (RCA) methodologies to identify underlying causes and define sustainable preventive actions.Lead investigations ranging from moderately complex to highly complex, including:Single‑system issuesMulti‑system or cross‑functional CEF events (e.g., system configuration changes, automation interfaces, data trending, and activities spanning multiple CEF disciplines)Provide technical input on engineering and maintenance issues, utility performance, asset reliability, and system configuration integrity.Documentation & Quality OversightDevelop, write, revise, and implement controlled documents (SOPs, specifications, work instructions, templates) supporting Facilities Operations and Engineering.Review documentation for accuracy, regulatory compliance, and alignment with operational intent.Perform high‑level quality reviews of technical data prior to senior management approval.Maintain programs and processes that ensure ongoing compliance with cGMPs and internal quality standards.Ensure quality records are clear, concise, complete, and inspection‑ready.Compliance, Audits & Inspection SupportSupport regulatory inspections and serve as an SME for Facilities, Utilities, Equipment, and Engineering Systems.Support internal and external audits, including preparation of documentation and written responses.Provide interpretation and guidance on cGMP, FDA, EU, and ICH regulations applicable to facilities and engineering systems.Maintain current knowledge of compliance requirements through training and participation in industry forums.Operational & Project ResponsibilitiesIdentify g