Director, Quality Systems & Compliance
$190,000–$260,000 year
On-site · Waltham, Massachusetts, United States
Job Summary
Director, Quality Systems & Compliance leads the strategy and oversight of Quality Systems, Compliance, and Business System Ownership to ensure regulatory alignment and data-driven operations. You will evolve the QMS into a digitally enabled, scalable ecosystem supporting clinical through commercial operations, serve as the primary host for client audits and regulatory inspections, drive AI-enabled quality solutions, ensure systems remain validated and compliant with Part 11, Annex 11, and CSA, and act as the QMS governance liaison across Quality, IT, and Data/AI teams. The role emphasizes adoption, user-centric design, and measurable improvements in efficiency and compliance while leveraging enterprise integrations (e.g., SAP, LIMS, MES) and emerging digital quality solutions.
Required Qualifications
- 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); 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
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