Senior Quality Audit & Compliance Leader

Ardelyx, Inc.; Waltham (MA); Hybrid; USD 188,000 - 230,000; Full time

Benefits offered by this job

401k match

Parental leave

Organ/bone marrow leave

Equity incentives

Health plans

Life insurance

Flexible time off

Holiday shutdown

Paid holidays

Job summary

Ardelyx, Inc. is seeking an Associate Director of Quality Auditing & Compliance to lead a risk-based internal audit program across GxP areas and Quality Systems.

The role ensures effective regulatory compliance, coordinates CAPAs, and supports inspection readiness within a hybrid environment with on-site work in Waltham, MA or Newark, CA. The position requires strong knowledge of FDA regulations, ICH guidelines, and data integrity, with 8–10 years of related experience and an advanced degree

Qualifications

• Bachelor’s degree in life sciences, pharmacy, engineering, or related field.
• 8–10 years of quality assurance/compliance or auditing in pharma/biotech.
• Experience leading GxP audits across multiple disciplines preferred.
• Strong knowledge of FDA regulations, ICH guidelines, Quality Systems, CAPA, data integrity.

Responsibilities

• Develop and execute the annual risk-based internal audit program across applicable GxP areas and Quality Systems.
• Plan, lead, document, and perform audits and other compliance assessments, including onsite audits of internal, external, and vendor/third-party audits.
• Evaluate compliance with FDA regulations, ICH guidelines, global regulatory requirements, and company procedures.
• Partner with stakeholders to develop CAPAs and monitor remediation.
• Identify systemic trends and communicate findings to Quality leadership.
• Support regulatory inspection readiness and mock inspections.
• Provide Quality Compliance guidance to cross-functional teams.
• Contribute to policy and governance improvements.

Skills

Quality auditing

Regulatory compliance

Risk assessment

CAPA management

FDA/ICH knowledge

Education

Bachelor’s degree in life sciences or related field

Advanced degree preferred

Tools

GxP auditing

Audit methodologies

Job description

Ardelyx, Inc. is seeking an Associate Director of Quality Auditing & Compliance to lead a risk-based internal audit program across GxP areas and Quality Systems.

The role ensures effective regulatory compliance, coordinates CAPAs, and supports inspection readiness within a hybrid environment with on-site work in Waltham, MA or Newark, CA. The position requires strong knowledge of FDA regulations, ICH guidelines, and data integrity, with 8–10 years of related experience and an advanced degree