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:
- 12+ years of biopharmaceutical experience with leadership in Quality Systems and Compliance
- Demonstrated experience as a Business System Owner / Digital Process Owner in a GxP environment
- Strong expertise in global GxP regulations and ability to translate requirements into practical solutions
- Experience with enterprise systems (eQMS, DMS, LMS, SAP, LIMS, MES); experience with Veeva Vault is preferred
- Experience driving digital transformation, automation, and advanced analytics initiatives
- Familiarity with AI/ML tools and digital quality solutions in regulated environments
- Strong understanding of data integrity, CSV/CSA, and digital system compliance requirements
- Proven ability to influence across functions and drive system adoption, performance improvements, and inspection readiness
- Demonstrated leadership in operational excellence, accountability, and continuous improvement
- Ability to operate effectively in a fully digital, data-driven environment
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.
Skills Required
- 12+ years of biopharmaceutical experience with leadership in Quality Systems and Compliance
- Demonstrated experience as a Business System Owner / Digital Process Owner in a GxP environment
- Strong expertise in global GxP regulations and ability to translate requirements into practical solutions
- Experience with enterprise systems (eQMS, DMS, LMS, SAP, LIMS, MES)
- Experience with Veeva Vault
- Experience driving digital transformation, automation, and advanced analytics initiatives
- Familiarity with AI/ML tools and digital quality solutions in regulated environments
- Strong understanding of data integrity, CSV/CSA, and digital system compliance requirements
- Proven ability to influence across functions and drive system adoption, performance improvements, and inspection readiness
- Demonstrated leadership in operational excellence, accountability, and continuous improvement
- Ability to operate effectively in a fully digital, data-driven environment
What We Do
ElevateBio is a technology driven company powering transformative cell and gene therapies today and for many decades to come. The company has assembled industry-leading talent, built world-class facilities, and integrated diverse technology platforms necessary for rapid innovation and commercialization of cell, gene, and regenerative therapies. The company has built an initial technology stack, including gene editing, induced pluripotent stem cells, and protein, viral, and cellular engineering. At the center of the business model is ElevateBio BaseCamp, a centralized R&D and manufacturing company that offers research and development (R&D), process development (PD), and Current Good Manufacturing Practice (CGMP) manufacturing capabilities. The company is focused on increasing long-term collaborations with industry partners while also continuing to develop its own highly innovative cell and gene therapies. ElevateBio's team of scientists, drug developers, and company builders are redefining what it means to be a technology company in the world of drug development, blurring the line between technology and healthcare. ElevateBio is headquartered in Cambridge, Mass, with ElevateBio BaseCamp located in Waltham, Mass.
