Elevatebio
Director, Quality Systems & Compliance
Waltham, Massachusetts, United States · Director
Sponsorship not specified$190k-$260kDetected 41 days ago
Machine LearningSAPLeadershipGxP
About the role
- 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.
- Digital System Ownership & AI Enablement
Responsibilities
- 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
- Lead regulatory inspections and client audits, ensuring effective preparation, execution, and follow-up
- Drive optimization through automation, advanced analytics, and native AI capabilities
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 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
- Ability to operate effectively in a fully digital, data-driven environment
Nice to have
- Experience with enterprise systems (eQMS, DMS, LMS, SAP, LIMS, MES)
- experience with Veeva Vault is preferred
Compensation
- 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
Benefits
- Lead the Quality Management Review (QMR) process, monitoring system health, identifying trends and risks, and driving continuous system and process improvements
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