Executive Director, QMS & Digital (Onsite)

About the role

Ardelyx, a commercial-stage biopharmaceutical company, is hiring an Executive Director, QMS and Digital for its Waltham, Massachusetts office. Reporting to the SVP, Head of Quality, the role is accountable for the strategy, governance, compliance and continuous improvement of the company's Quality Management System (QMS), and for the digital and data capabilities that support a modern QMS. It is a hybrid role with 2-3 days per week onsite.

Key responsibilities

• Own the overall QMS, including its strategy, governance, compliance, effectiveness, inspection readiness and continuous improvement.
• Lead core QMS processes such as document control and training, CAPA, change control, quality events and deviations.
• Set up QMS governance and performance management using risk, metrics, trends and management review.
• Drive Quality Process Excellence, simplifying and standardizing processes while keeping compliance and controls.
• Develop and execute the Quality digital strategy and roadmap, including digital platforms and automation with IT and other stakeholders.
• Own Quality metrics and data infrastructure, and provide oversight for computerized system validation (CSV) and data integrity.
• Lead and develop a team and act as a senior Quality partner during regulatory inspections, audits and other assessments.

Required profile

• Bachelor's degree, advanced degree preferred; 15+ years of Quality experience in life sciences, including 8+ years of GMP experience.
• Deep expertise in QMS strategy, governance and core Quality processes (document management, training, CAPA, change control, deviations, investigations).
• Knowledge of global GxP requirements and experience maintaining inspection-ready systems and supporting or leading regulatory inspections and audits.
• Experience in Quality process excellence, digital transformation, Quality data and analytics, and regulated technology environments including CSV and data integrity.
• Understanding of responsible use of emerging AI technologies, including governance, risk, validation and compliance.
• Ability to lead teams, influence stakeholders and travel domestically and internationally up to 20%.

What we offer

• Anticipated annualized base pay of $252,000 - $308,000, with possible annual bonus target and equity awards.
• 401(k) with employer match, 12 weeks of paid parental leave, equity incentive plans.
• Health, life insurance and disability coverage, and at least 11 paid holidays.