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 Leadership
Lead and continuously improve Quality Systems, including Document Management, Training, CAPA, Deviations, Change Control, Risk Management, Supplier Quality, and Audit/Inspection Management
Own and drive the program for continuous inspection readiness, ensuring sustained audit preparedness through proactive monitoring, internal audits, and system effectiveness
Serve as the primary host and lead for client audits, including preparation, on-site execution, stakeholder coordination, and audit response strategy
Lead regulatory inspections and client audits, ensuring effective preparation, execution, and follow-up
Lead the Quality Management Review (QMR) process, monitoring system health, identifying trends and risks, and driving continuous system and process improvements
Digital System Ownership & AI Enablement
Serve as Business System Owner for eQMS, DMS, and LMS, accountable for system strategy, lifecycle, performance, and adoption
Drive optimization through automation, advanced analytics, and native AI capabilities
Implement AI-enabled use cases such as:
Predictive quality signal detection and trending
Deviation and CAPA pattern recognition
Automated reviews, compliance checks, and standardization of quality processes
Intelligent workflow routing and prioritization
Ensure systems remain validated and compliant with Part 11, Annex 11, and CSA expectations, while improving operational efficiency
Quality System Adoption & Value Realization
Act as a primary influencer for enterprise-wide adoption and effective use of Quality Systems
Ensure systems are user-centric, efficient, and enable improved execution of quality processes
Translate regulatory requirements into solutions that improve efficiency and support business objectives
Partner with functional leaders to enable transparent, compliant, and effective operations
Quality-IT-Digital Integration
Serve as the primary interface between Quality, IT, and Data/AI teams, translating business needs into scalable digital solutions
Ensure integration with enterprise platforms (e.g., SAP, LIMS, MES) and support implementation of emerging technologies
Operational Excellence & Transformation
Act as a Quality Operational Excellence Champion, driving process simplification, standardization, and cycle time improvements
Eliminate non-value-added activities and improve right-first-time performance
Establish and track metrics for system effectiveness, adoption, and process efficiency
Business System Governance
Lead the QMS Business System Governance process, including ownership, accountability, and prioritization of enhancements for the QMS systems
Participate in governance forums (e.g., Digital Steering Committees, System Boards)
Serve as the primary escalation point for systemic Quality System issues
Leadership & Culture
Serve as a thought leader in modern Quality Systems, advancing innovation and continuous improvement
Foster a culture of open-minded thinking, accountability, and innovation
Hold teams accountable for system utilization and performance outcomes, while empowering new ideas and approaches
Requirements:
The 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.