Senior Quality Auditing & Compliance Leader

Ardelyx, Inc.; Northern (KY); Hybrid; USD 188,000 - 230,000; Full time

Benefits offered by this job

401(k) match

Parental leave 12 weeks

Organ and bone marrow leave

Equity incentive plans

Health plans

Life insurance

Disability insurance

Flexible time off

Winter Holiday shutdown

Paid holidays

Job summary

Ardelyx, Inc. is seeking an Associate Director of Quality Auditing & Compliance to lead the risk-based internal audit program and ensure compliance with applicable GxP regulations and regulatory requirements. The role partners with functional leaders to drive timely remediation and supports inspection readiness.

The position requires 8–10 years in Quality Assurance/Compliance with strong knowledge of FDA regulations, ICH guidelines, CAPA, and data integrity. Travel 30–40% is expected.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, engineering, or related field.
• 8–10 years of progressive experience in Quality Assurance, Quality Compliance, auditing, or related functions.
• Significant experience conducting and leading GxP audits and compliance assessments; experience across multiple GxP disciplines preferred.
• Strong knowledge of FDA regulations, ICH guidelines, Quality Systems, CAPA, data integrity, and global regulatory requirements.
• Auditor certification or equivalent preferred.
• Ability to travel domestically and internationally 30–40%.

Responsibilities

• Develop, maintain, 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, procedures, and standards.
• Partner with stakeholders to develop CAPAs and monitor remediation.
• Identify systemic trends and communicate findings to Quality leadership.
• Support regulatory inspection readiness and post-inspection remediation.
• Provide Quality Compliance guidance to cross-functional teams and promote a culture of quality.

Skills

Audit leadership

Regulatory knowledge

Communication

Risk assessment

GxP auditing

Cross-functional influence

Travel flexibility

Education

Bachelor’s degree in life sciences or related

Advanced degree preferred

Job description

Ardelyx, Inc. is seeking an Associate Director of Quality Auditing & Compliance to lead the risk-based internal audit program and ensure compliance with applicable GxP regulations and regulatory requirements. The role partners with functional leaders to drive timely remediation and supports inspection readiness.

The position requires 8–10 years in Quality Assurance/Compliance with strong knowledge of FDA regulations, ICH guidelines, CAPA, and data integrity. Travel 30–40% is expected.