Senior QMS Operations Leader

Ardelyx; Waltham (MA); Hybrid; USD 176,000 - 215,000; Full time

Benefits offered by this job

401(k) plan with match

Parental leave

Living organ and bone marrow leave

Equity incentives

Health plans

Job summary

Ardelyx is seeking an Associate Director, QMS Operations to lead Deviations, CAPA, Complaints and Change Control with governance and continuous improvement across the QMS. The role partners with Quality, Manufacturing, Regulatory and Supply Chain to drive risk-based processes and a strong quality culture.

The position supports regulatory inspections, internal audits, and process harmonization, while advancing electronic QMS tools and data-driven decision making in a hybrid Waltham environment.

Qualifications

• Bachelor's degree or higher in a scientific/engineering/quality field; advanced degree preferred.
• Strong knowledge of Deviations, CAPA, investigations and product complaints.
• Familiarity with GxP requirements and regulatory expectations.
• Experience leading enterprise-level Quality processes and continuous improvement.

Responsibilities

• Serve as enterprise QMS process owner for Deviations, CAPA, and Complaints, and other assigned processes, establishing process standards, governance, and performance expectations
• Maintain and continuously improve associated procedures, workflows, systems, and training to ensure effective and consistent process execution
• Provide subject matter expertise and oversight for investigations, root cause analysis, CAPA development, and effectiveness checks related to the systems
• Monitor process health through KPIs, trends, and Quality data; identify emerging risks and systemic issues and drive corrective actions and process improvements
• Partner cross-functionally with Quality, Manufacturing, Supply Chain, Regulatory, Medical, and other stakeholders to ensure timely and effective issue resolution and consistent application of QMS requirements
• Ensure QMS processes meet applicable GxP regulations, regulatory commitments, and internal Quality standards
• Support regulatory inspections, audits, management reviews, and responses related to Deviations, CAPA, Complaints, Change Control and others as identified
• Lead process harmonization and continuous improvement initiatives, including optimization of electronic QMS tools and workflows to improve process effectiveness, compliance, and operational efficiency

Skills

Deviations

CAPA

Root cause analysis

Product complaints

GxP knowledge

Regulatory inspections

Cross-functional collaboration

Education

Bachelor's degree

Advanced degree preferred

Job description

Ardelyx is seeking an Associate Director, QMS Operations to lead Deviations, CAPA, Complaints and Change Control with governance and continuous improvement across the QMS. The role partners with Quality, Manufacturing, Regulatory and Supply Chain to drive risk-based processes and a strong quality culture.

The position supports regulatory inspections, internal audits, and process harmonization, while advancing electronic QMS tools and data-driven decision making in a hybrid Waltham environment.