Executive Director, QMS & Digital

Ardelyx, Inc.; Waltham (MA); Hybrid; USD 252,000 - 308,000; Full time

Benefits offered by this job

401(k) match

Parental leave

Organ/bone marrow leave

Equity incentive plans

Health insurance

Life insurance

Disability insurance

Flexible time off

Winter Holiday shutdown

Paid holidays

Job summary

Ardelyx, Inc. is seeking an Executive Director, QMS and Digital, a senior Quality leader responsible for strategy, governance, and continuous improvement of the QMS in a commercial-stage biotech environment.

You will own document control, training, CAPA, change control, quality events, and CSV while leading a team and partnering across the organization to ensure inspection readiness and data-driven decisions.

Qualifications

• Senior leadership for QMS strategy, governance, and compliance.
• Experience in quality systems, document control, training, and CAPA.
• Proven ability to improve quality metrics and enable data-driven decisions.

Responsibilities

• Own the overall QMS strategy, governance, compliance, and improvement.
• Lead core QMS processes: document control, training, CAPA, change control.
• Establish governance with metrics, trends, and management reviews.
• Drive Quality Process Excellence to simplify and standardize processes.
• Develop and execute Quality digital strategy and roadmap with IT partners.
• Own Quality metrics/data infrastructure for actionable insights.
• Oversee CSV and data integrity across Quality systems.
• Lead a high-performing team and partner during inspections/audits.

Skills

QMS governance

Digital strategy

Quality leadership

CAPA & change control

Regulatory inspections

Data analytics

Team building

Process optimization

Tools

CSV validation

Job description

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.

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 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

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.
Ardelyx is an equal opportunity employer.