DescriptionThis is hybrid role with 2-3 days per week onsite in our Waltham, MA officePosition Summary: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.
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
Qualifications:- 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%
The anticipated annualized base pay range for this full-time position is $252,000 - $308,000 Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.
Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.
