Associate Director, Quality Assurance

Associate Director, Quality Assurance ComplianceAt 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.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.We prefer a candidate that is site-based (local to Foster City). You will be on site Tuesday, Wednesday, Thursday. For non-local talent, we are open to remote.As an Associate Director, Quality Assurance Compliance at Gilead you will have the following responsibilities:Inspection Operation and Logistics (Foster City):Manages the logistics to support regulatory inspections at GSI Foster City including notification process, inspection support team (IST), prep room and inspection rooms and post-inspection activitiesBuild inspection readiness tools, templates and training materials for perpetual readiness for GSI FC – including inspection system training, inspection support team (host, scribe, request champion, SMEs, Facilities, IT etc.)Provide logistics support for partner audits including training, inspection coordination and prep room support.Management of all inspection related documentation including document retention and tracking (pre-inspection notification, documents reviewed/retained/requested by investigator/agency)Management of post-inspection activities including upload of inspection documents in GVault; coordination and assessment of inspection observation response from key stakeholders, maintenance of evidence binder and coordination of the inspection readiness of the evidence binders and/or storyboardsManagement of inspection systems utilized to support inspections including guides, tools, troubleshooting and training (i.e. MSTeams, Sharepoint, Zoom)Coordinate site inspection logistics with the different cross functional groups including general notification, investigator needs, conference room set-up (printers, boards, zoom, phones, office supplies, laptops, iPad/cart for virtual tours) and inspection support team assignment and scheduleDevelop and maintenance of Inspection Readiness MSTeams/SharePoint as a centralized resource for inspection readiness support and resources for FC PDM OrganizationGeneral and PAI Readiness (Foster City and Global):Responsible for the management and maintenance of regulatory inspection procedures and documentation including Regulatory Inspection Policy, Site Master File, Opening Presentation and other related proceduresLead PAI readiness activities by partnering with project teams to evaluate inspection readiness of the team including coordination of a mock inspection as neededLead periodic inspection readiness activities for GSI FC including annual mock inspection, inspection logistics drill, inspection readiness meeting with different function areas that will support and participate during an inspection (Management, Inspection Support Team, Security, Administrative Assistance, Facilities and IT)Lead global inspection readiness activities and meetings to share best practices and collaborate on inspection readiness topics and projects; identify and drive improvementsMay support mock PAI inspections as part of audit teamOversees the provision of inspection related trainingDeveloping and Implementing Inspection Strategies:Design and implement comprehensive inspection plans for all manufacturing sites, including raw materials, in-process materials, and finished products, aligned with regulatory requirements.Establish standardized inspection procedures and methodologies across global operations.Oversee the implementation of advanced inspection technologies to enhance accuracy and efficiency.Regulatory Compliance:Stay abreast of all relevant regulatory requirements related to product quality, data integrity, and supplier management.Ensure compliance with regulatory agencies like FDA, EMA, and other relevant authorities.Assesses proposed corrective or preventive actions in response to audit or inspection findings, tracks, and reports closure of items, and provides management visibility to areas of risk or concern.Act as liaison for regulatory inspection for GSI FC PDM inquiries (such as license renewal, manufacturer's questionnaire, drug manufacturing license etc.)Quality Improvement Initiatives:Lead or support continuous improvement efforts within Inspection Management to enhance quality standards and operational efficiency.Analyze quality data to identify inspection trends and opportunities for improvement.Digital, Data & AI?Enabled Inspection Readiness:Leverage data analytics, digital tools, and emerging AI?enabled capabilities to enhance inspection readiness, inspection intelligence, and risk identification across sites.Partner with Quality, IT, and Digital teams to evaluate, pilot, and operationalize AI?supported tools (e.g., document triage, trend detection, inspection metrics dashboards) in a GxP?compliant and inspection?defensible manner.Ensure AI?enabled solutions used in inspection preparation and execution are appropriately governed, validated where required, and aligned with data integrity, cybersecurity, and privacy expectations.Use inspection data, audit outcomes, and quality signals to support risk?based decision?making and continuous improvement initiatives.Other:May support Audit Programs including internal audits, site audits, affiliate and 3PL audits, as neededPosition may include travel (~up to 50%)Other responsibilities as requiredRequirements:BS/BA degree in Biology, Sciences, or related discipline and a minimum of 10+ years of related experience; ORMS/MA degree in Biology, Sciences, or related discipline and a minimum of 8+ years of related experience; ORPhD in related discipline and a minimum of 5+ years of related experienceKnowledge & Behaviors:Experience in the biotech or pharmaceutical industry is required.Experience in managing Health Authorities during inspection; previous Regulatory Health Agency investigator experience preferredExperience in managing Customer/Business Partners during inspection. Knowledge and practical application of domestic and global regulations including 21 CFR Parts 4, 11, 203, 205, 210, 211, 600, 610, 820; EudraLex Volume 4 and applicable annexes; EU Good Distribution Practices for Medicinal Products, QMSR/ISO13485 and Health Canada GMP/GDP guidance; as well as ICH, ISO and USP / EP compendial standardsDetailed knowledge of the manufacturing and testing processes associated with APIs, Oral Solid Drug Product, Liquid Formulations, Biologics, Aseptic Fill / Finish, Primary and Secondary Packaging, Medical Device and Warehousing / DistributionApplies most current market regulations, functional trends, quality standards, and techniques to deliver high quality workWell recognized as a knowledgeable and credible resource for QA compliance in other departmentsIn-depth knowledge of audit process and risk-based principlesExcellent knowledge of computer systems; i.e. Microsoft Word, Excel, Powerpoint, MSTeams, and Veeva VaultWorking knowledge of AI, machine learning, and advanced analytics concepts as applied to Quality, Compliance, and Inspection Management.Experience using or supporting digital quality systems and analytics platforms (e.g., dashboards, document management systems, inspection intelligence tools) to improve inspection outcomes and operational efficiency.Understanding of AI governance principles, including data integrity, validation expectations, human oversight, and appropriate use in regulated GxP environments.Ability to translate complex data and AI