Executive Director, QMS & Digital

Ardelyx•Waltham, MA

1d•$252,000 - $308,000•Hybrid

About The Position

The Executive Director, QMS and Digital is a senior leader within the Quality organization, reporting to the SVP, Head of Quality. This role is accountable for the strategy, governance, effectiveness, compliance, and continuous improvement of the Company’s Quality Management System (QMS), ensuring it operates as an integrated, reliable, and scalable system supporting a commercial-stage biotechnology organization. This role serves as the enterprise Quality owner for the QMS, including governance, processes, and frameworks for document control and training, CAPA, change control, quality events and deviations and process excellence. The role is accountable for ensuring the QMS remains compliant, inspection-ready, available, and effective, with clear standards and ongoing evaluation of system performance. This leader also owns the digital and data capabilities that enable a modern QMS, including Quality digital and AI strategy, Quality metrics and data infrastructure, and computerized system validation (CSV). The Executive Director leads and develop a team and partner across the organization to simplify processes, strengthen compliance, improve visibility and decision-making, and continuously advance Quality capabilities.

Requirements

Bachelor’s degree, advanced degree preferred, with 15+ years of Quality experience, within the life sciences industry, including 8+ years of GMP experience.
Deep expertise in QMS strategy and governance, as well as core Quality processes, including document management, training, CAPA, change control, deviations/quality events, investigations, and management oversight
Strong knowledge of global GxP requirements and demonstrated experience maintaining inspection-ready Quality systems and supporting or leading regulatory inspections and audits
Demonstrated experience in Quality process excellence, digital transformation, Quality data and analytics, and evolving regulated technology environments, including CSV and data integrity
Demonstrated understanding of the responsible use of emerging AI technologies, including 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, and translate strategy into practical execution and measurable outcomes.
Strong strategic and systems thinking, judgment, communication, and change-leadership skills, with the ability to balance compliance, Quality risk, operational effectiveness, technology, and business needs
Ability to travel domestically and internationally up to 20%

Responsibilities

Own and be accountable for the overall QMS, including its strategy, governance, compliance, effectiveness, reliability, inspection readiness, and continuous improvement
Lead core QMS processes and frameworks, including document control and training, CAPA, change control, quality events and deviations, ensuring clear standards, effective execution, appropriate oversight, and strong interfaces across the system
Establish QMS governance and performance management, using risk, metrics, trends, and management review to assess system health, identify emerging issues, and drive timely actions and continuous improvement
Lead Quality Process Excellence, simplifying, standardizing, and optimizing processes to improve effectiveness and user experience while maintaining appropriate compliance and controls
Develop and execute the Quality digital strategy and roadmap, including digital platforms, and automation in partnership with IT and other stakeholders
Own the Quality metrics and data infrastructure, enabling reliable, actionable insights and increasing use of analytics and trend detection to support proactive Quality management and decision-making
Provide leadership and oversight for computerized system validation (CSV), data integrity, and the compliant lifecycle management of Quality systems
Lead and develop a high-performing team and serve as a senior Quality partner across the organization, including during regulatory inspections, audits, and other external assessments