Director, Quality Systems & Compliance

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.The Role:The Director, Quality Systems and Compliance provides strategic direction and oversight of Quality Systems, Compliance, and Business System Ownership to ensure execution meets regulatory requirements, industry best practices, and modern digital, data-driven expectations.This role is accountable for evolving the Quality Management System (QMS) into a digitally enabled, scalable, and continuously improving ecosystem supporting clinical through commercial operations. The incumbent serves as a senior Digital System Owner leader, transforming Quality Systems into intelligent, data-driven platforms that enhance compliance, improve operational performance, and enable decision-making.This role is a critical influencer across the organization, driving adoption and effective use of Quality Systems and ensuring they deliver measurable business value. Success requires leadership beyond traditional system management—delivering value from systems by translating compliance requirements into efficient, practical, and scalable solutions that enable the business to operate effectively and transparently while maintaining a strong compliance posture.Here’s What You’ll Do:Quality Systems LeadershipLead and continuously improve Quality Systems, including Document Management, Training, CAPA, Deviations, Change Control, Risk Management, Supplier Quality, and Audit/Inspection ManagementOwn and drive the program for continuous inspection readiness, ensuring sustained audit preparedness through proactive monitoring, internal audits, and system effectivenessServe as the primary host and lead for client audits, including preparation, on-site execution, stakeholder coordination, and audit response strategyLead regulatory inspections and client audits, ensuring effective preparation, execution, and follow-upLead the Quality Management Review (QMR) process, monitoring system health, identifying trends and risks, and driving continuous system and process improvementsDigital System Ownership & AI EnablementServe as Business System Owner for eQMS, DMS, and LMS, accountable for system strategy, lifecycle, performance, and adoptionDrive optimization through automation, advanced analytics, and native AI capabilitiesImplement AI-enabled use cases such as:Predictive quality signal detection and trendingDeviation and CAPA pattern recognitionAutomated reviews, compliance checks, and standardization of quality processesIntelligent workflow routing and prioritizationEnsure systems remain validated and compliant with Part 11, Annex 11, and CSA expectations, while improving operational efficiencyQuality System Adoption & Value RealizationAct as a primary influencer for enterprise-wide adoption and effective use of Quality SystemsEnsure systems are user-centric, efficient, and enable improved execution of quality processesTranslate regulatory requirements into solutions that improve efficiency and support business objectivesPartner with functional leaders to enable transparent, compliant, and effective operationsQuality–IT–Digital IntegrationServe as the primary interface between Quality, IT, and Data/AI teams, translating business needs into scalable digital solutionsEnsure integration with enterprise platforms (e.g., SAP, LIMS, MES) and support implementation of emerging technologiesOperational Excellence & TransformationAct as a Quality Operational Excellence Champion, driving process simplification, standardization, and cycle time improvementsEliminate non-value-added activities and improve right-first-time performanceEstablish and track metrics for system effectiveness, adoption, and process efficiencyBusiness System GovernanceLead the QMS Business System Governance process, including ownership, accountability, and prioritization of enhancements for the QMS systemsParticipate in governance forums (e.g., Digital Steering Committees, System Boards)Serve as the primary escalation point for systemic Quality System issuesLeadership & CultureServe as a thought leader in modern Quality Systems, advancing innovation and continuous improvementFoster a culture of open-minded thinking, accountability, and innovationHold teams accountable for system utilization and performance outcomes, while empowering new ideas and approachesRequirements:12+ years of biopharmaceutical experience with leadership in Quality Systems and ComplianceDemonstrated experience as a Business System Owner / Digital Process Owner in a GxP environmentStrong expertise in global GxP regulations and ability to translate requirements into practical solutionsExperience with enterprise systems (eQMS, DMS, LMS, SAP, LIMS, MES); experience with Veeva Vault is preferredExperience driving digital transformation, automation, and advanced analytics initiativesFamiliarity with AI/ML tools and digital quality solutions in regulated environmentsStrong understanding of data integrity, CSV/CSA, and digital system compliance requirementsProven ability to influence across functions and drive system adoption, performance improvements, and inspection readinessDemonstrated leadership in operational excellence, accountability, and continuous improvementAbility to operate effectively in a fully digital, data-driven environmentThe budgeted range for this position is $190,000 - $260,000. This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law. ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.