Senior QMS Operations & CAPA Lead

Ardelyx, Inc.; Waltham, Northern (MA, KY); Hybrid; USD 176,000 - 215,000; Full time

Benefits offered by this job

401(k) match

Paid parental leave

Living organ and bone marrow leave

Equity incentive plans

Health plans (medical, prescription, &

Dental & vision

Life insurance & disability

Flexible time off

Winter Holiday shutdown

11 paid holidays

Job summary

Ardelyx, Inc. seeks an Associate Director, QMS Operations to provide strategic oversight of critical Quality Management System processes with accountability for Deviations, CAPA, Product Complaints and Change Control.

This hybrid role requires collaboration across Quality, Manufacturing, Regulatory, and Medical, ensuring risk-based, compliant execution. You will drive continuous improvement, establish governance standards, and harmonize QMS workflows while supporting regulatory inspections and

Qualifications

• Bachelor’s degree in scientific, quality, or related discipline; 8–10 years in quality within regulated life sciences.
• Strong expertise in Deviations, CAPA, investigations/root cause analysis, and product complaint processes.
• Knowledge of GxP requirements and FDA/global regulatory expectations.
• Experience as a QMS process owner or leading enterprise-level Quality processes and continuous improvement initiatives.
• Excellent verbal and written communication, and ability to influence cross-functional stakeholders.

Responsibilities

• Serve as the enterprise QMS process owner for Deviations, CAPA, and Complaints and other assigned processes.
• Maintain and improve procedures, workflows, systems, and training for effective process execution.
• Oversee investigations, root cause analysis, CAPA development, and effectiveness checks.
• Monitor process health via KPIs, trends, and quality data; address risks and drive improvements.
• Collaborate cross-functionally with Quality, Manufacturing, Supply Chain, Regulatory, Medical, and others.
• Ensure QMS processes meet applicable GxP and regulatory commitments.
• Support regulatory inspections and audits related to Deviations, CAPA, Complaints, Change Control.
• Lead process harmonization and optimization of electronic QMS tools.

Skills

QMS ownership

CAPA investigations

Deviation management

Quality metrics & data

Cross-functional collaboration

Regulatory inspections support

Process harmonization

Education

Bachelor's degree

Advanced degree preferred

Tools

QMS software

Job description

Ardelyx, Inc. seeks an Associate Director, QMS Operations to provide strategic oversight of critical Quality Management System processes with accountability for Deviations, CAPA, Product Complaints and Change Control.

This hybrid role requires collaboration across Quality, Manufacturing, Regulatory, and Medical, ensuring risk-based, compliant execution. You will drive continuous improvement, establish governance standards, and harmonize QMS workflows while supporting regulatory inspections and