Executive Director, QMS & Digital
Ardelyx, Inc.
August 14, 2026
Remote friendly (Waltham, MA)
United States
Operations
Position Summary:
- Own and be 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.
- Serve as enterprise Quality owner for QMS governance, processes, and frameworks for document control and training, CAPA, change control, quality events and deviations, and process excellence.
- Own digital and data capabilities enabling a modern QMS, including Quality digital and AI strategy, Quality metrics and data infrastructure, and computerized system validation (CSV). Lead/develop teams and partner across the organization.
Responsibilities:
- Own overall QMS performance: compliance, effectiveness, reliability, inspection readiness, continuous improvement.
- Lead core QMS processes: document control/training, CAPA, change control, quality events/deviations.
- Establish governance and performance management using risk, metrics, trends, and management review.
- Lead Quality Process Excellence to simplify/standardize/optimize processes while maintaining compliance.
- Develop and execute Quality digital strategy/roadmap and automation (with IT and stakeholders).
- Own Quality metrics and data infrastructure to enable actionable insights and proactive management.
- Provide oversight for CSV, data integrity, and compliant lifecycle management of Quality systems.
- Lead and develop a high-performing team; serve as senior Quality partner for inspections, audits, and external assessments.
Qualifications:
- Bachelor’s degree (advanced degree preferred). 15+ years Quality experience in life sciences; 8+ years GMP experience.
- Deep QMS strategy/governance expertise and core QMS processes (document management, training, CAPA, change control, deviations/quality events, investigations, management oversight).
- Knowledge of global GxP; experience maintaining inspection-ready QMS and supporting/leading inspections and audits.
- Experience in Quality process excellence, digital transformation, Quality data/analytics, regulated technology environments (CSV, data integrity).
- Understanding of responsible AI use in regulated environments (governance, risk, validation, compliance).
- Proven leadership and ability to influence stakeholders and translate strategy into measurable execution.
- Strong systems thinking, judgment, communication, and change leadership; ability to balance compliance, risk, operational effectiveness, technology, and business needs.
- Travel up to 20%.
Benefits:
- 401(k) with generous employer match; 12 weeks paid parental leave; up to 12 weeks living organ and bone marrow leave; equity incentive plans; medical/prescription/dental/vision; life insurance and disability; flexible time off; Winter Holiday shutdown; at least 11 paid holidays.
- Own and be 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.
- Serve as enterprise Quality owner for QMS governance, processes, and frameworks for document control and training, CAPA, change control, quality events and deviations, and process excellence.
- Own digital and data capabilities enabling a modern QMS, including Quality digital and AI strategy, Quality metrics and data infrastructure, and computerized system validation (CSV). Lead/develop teams and partner across the organization.
Responsibilities:
- Own overall QMS performance: compliance, effectiveness, reliability, inspection readiness, continuous improvement.
- Lead core QMS processes: document control/training, CAPA, change control, quality events/deviations.
- Establish governance and performance management using risk, metrics, trends, and management review.
- Lead Quality Process Excellence to simplify/standardize/optimize processes while maintaining compliance.
- Develop and execute Quality digital strategy/roadmap and automation (with IT and stakeholders).
- Own Quality metrics and data infrastructure to enable actionable insights and proactive management.
- Provide oversight for CSV, data integrity, and compliant lifecycle management of Quality systems.
- Lead and develop a high-performing team; serve as senior Quality partner for inspections, audits, and external assessments.
Qualifications:
- Bachelor’s degree (advanced degree preferred). 15+ years Quality experience in life sciences; 8+ years GMP experience.
- Deep QMS strategy/governance expertise and core QMS processes (document management, training, CAPA, change control, deviations/quality events, investigations, management oversight).
- Knowledge of global GxP; experience maintaining inspection-ready QMS and supporting/leading inspections and audits.
- Experience in Quality process excellence, digital transformation, Quality data/analytics, regulated technology environments (CSV, data integrity).
- Understanding of responsible AI use in regulated environments (governance, risk, validation, compliance).
- Proven leadership and ability to influence stakeholders and translate strategy into measurable execution.
- Strong systems thinking, judgment, communication, and change leadership; ability to balance compliance, risk, operational effectiveness, technology, and business needs.
- Travel up to 20%.
Benefits:
- 401(k) with generous employer match; 12 weeks paid parental leave; up to 12 weeks living organ and bone marrow leave; equity incentive plans; medical/prescription/dental/vision; life insurance and disability; flexible time off; Winter Holiday shutdown; at least 11 paid holidays.