Executive Director, QMS & Digital
$252,000–$308,000 year
HybridWaltham, Massachusetts, United States
Job Summary
Own the Quality Management System strategy, governance, and compliance, ensuring inspection readiness and continuous improvement across document control, training, CAPA, change control, and quality events. Lead core QMS processes and establish performance management using risk, metrics, and trends to drive timely actions. Develop and execute the digital strategy and roadmap, including automation and computerized system validation, while owning the data infrastructure for actionable insights. Provide leadership for a high-performing team and serve as a senior partner during regulatory inspections and audits. This hybrid role includes 2-3 days onsite in Waltham, MA, with up to 20% international travel.
Required Qualifications
- Bachelor's degree
- 15+ years of Quality experience
- within the life sciences industry
- 8+ years of GMP experience
- Deep expertise in QMS strategy and governance
- core Quality processes, including document management, training, CAPA, change control, deviations/quality events, investigations, and management oversight
- Strong knowledge of global GxP requirements
- demonstrated experience maintaining inspection-ready Quality systems
- supporting or leading regulatory inspections and audits
- Demonstrated experience in Quality process excellence
- digital transformation
- Quality data and analytics
- evolving regulated technology environments, including CSV and data integrity
- Demonstrated understanding of the responsible use of emerging AI technologies
- governance, risk, validation, and compliance considerations associated with their use in regulated environments
- Proven ability to lead and develop teams
- influence senior and cross-functional stakeholders
- translate strategy into practical execution and measurable outcomes
- Strong strategic and systems thinking
- judgment
- communication
- change-leadership skills
- Ability to travel domestically and internationally up to 20%
Desired Qualifications
- advanced degree
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