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Executive Director, QMS & Digital

Ardelyx

Job Location:

Waltham, MA - USA

Yearly Salary: USD 252000 - 308000

Posted: 29 September 2026 (Yesterday)

Application Deadline: 27 December 2026

Vacancies: 1 Vacancy

Job Summary

Description

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative purpose-driven culture we strive to create meaningful impact for patients.

Team Ardelyx is united by a shared mission and guided by our core values: Passionate Fearless Dedicated and Inclusive.

We foster an inclusive environment where employees are respected supported and empowered to make an impact both within our company and in the lives of patients we serve.

This is hybrid role with 2-3 days per week onsite in our Waltham MA office

Position 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 Companys 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:

Bachelors 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 $252000 - $308000 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.

Ardelyx is an equal opportunity employer.

We do not accept unsolicited resumes from search firms or recruiters or similar vendors. Any such unsolicited resume submitted to any employee or through Companys career site without a valid signed search agreement signed by Companys authorized representative will be deemed the property of the company and no fees will be paid in the event of a hire. Company will have the right to hire any such candidate at its discretion without any financial obligation or fee owed to the vendor. Any verbal or written communication with a Company employee outside of this process will not be considered a binding agreement.

Required Experience:

Director

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