Director/Associate Director, Quality Management Systems

The Director/Associate Director, Quality Management Systems, reporting directly to the Senior Director, Head of Quality, will be responsible for the global Quality Management System (QMS). This role is responsible for key elements of the QMS including Document Control, Records Management, Training, Deviation and CAPA, Change Control and some Risk Management responsibilities. Ensuring these systems are inspection-ready, risk-based, and aligned with global regulatory expectations. This position partners cross-functionally to embed quality as a strategic enabler of business performance, ensuring systems are fit-for-purpose, inspection-ready, scalable, and efficient as the organization grows. This is a hands-on role that requires both strategic vision and operational execution. The Director/Associate Director, QMS will help to establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance and inspection readiness with regards to quality requirements, and regulatory standards while supporting continuous improvement and the potential of commercialization. The ideal candidate will be based in the Boston area with 3 days in office in Norwood, MAEssential Functions and Duties:QMS Functional ResponsibilitiesLead and continuously improve Quality Systems, including Document Control/Management, Training, CAPA, Deviations, Change Control and Risk ManagementOversee the end-to-end lifecycle management of quality documents, including policies, SOPs, and related controlled records, ensuring consistency, accuracy, and compliance with applicable regulations that achieves inspection readiness Support and manage document authoring, revision, and implementation Lead the planning, deployment, and governance of role-based training curriculum across functions Lead the design and implementation of learning programs (refresher training, cross-training, etc.) Support and sometimes lead Deviations and CAPA, Change Controls and Risk Management responsibilitiesSupport and help lead the Quality functions for continuous inspection readiness, ensuring sustained audit preparedness through proactive monitoringSupport regulatory inspections and client audits, ensuring effective preparation, execution, and follow-upPartner with cross-functional stakeholders to embed quality into business processes and decision-making Support the Quality Management Review (QMR) process, monitoring system health, identifying trends and risks, and driving continuous system and process improvementseQMS System RequirementsServe as Quality System Owner for eQMS, accountable for system strategy, lifecycle, performance, and adoptionEnsure systems remain validated and compliant with Part 11, Annex 11, and CSA expectations, while improving operational efficiencyLead or oversee eQMS validation, maintenance and implementationHold teams accountable for system utilization and performance outcomes, while empowering new ideas and approachesAct as a primary influencer for enterprise-wide adoption and effective use of Quality SystemsAct 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 efficiencyLead the QMS Business System Governance process, including ownership, accountability, and prioritization of enhancements for the QMS systemsFoster a culture of open-minded thinking, accountability, and innovation