Hybrid: Senior Quality Auditing & Compliance Lead

Ardelyx, Inc.; Newark (CA); Hybrid; USD 188,000 - 230,000; Full time

Benefits offered by this job

401(k) plan with employer match

Paid parental leave

Equity incentive plans

Health plans

Job summary

Ardelyx, Inc. is seeking an Associate Director of Quality Auditing & Compliance to lead the internal audit program and assess compliance with GxP and regulatory requirements.

This role partners with stakeholders to drive timely remediation and supports inspection readiness. You will serve as a senior QA subject matter expert, shaping policies, metrics, and governance while ensuring Quality systems continuous improvement and effective risk management across the organization.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, engineering, or related discipline.
• 8–10 years of progressive experience in Quality Assurance, Quality Compliance, auditing, or related functions within the pharmaceutical or biotechnology industry.
• Significant experience conducting and leading GxP audits and compliance assessments; cross-discipline audits preferred.

Responsibilities

• Develop, maintain, and execute the annual risk-based internal audit program across GxP areas and Quality Systems.
• Plan, lead, document, and perform audits and compliance assessments with clear observations and risks.
• Evaluate compliance with FDA regulations, ICH guidelines, global 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.

Skills

Communication skills

Cross-functional collaboration

Auditing

Independent judgement

Education

Bachelor’s degree

Advanced degree preferred

Job description

Ardelyx, Inc. is seeking an Associate Director of Quality Auditing & Compliance to lead the internal audit program and assess compliance with GxP and regulatory requirements.

This role partners with stakeholders to drive timely remediation and supports inspection readiness. You will serve as a senior QA subject matter expert, shaping policies, metrics, and governance while ensuring Quality systems continuous improvement and effective risk management across the organization.