Senior Quality Audit & Compliance Lead (Hybrid)

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

Benefits offered by this job

401(k) plan

Parental leave

Organ/bone marrow leave

Equity incentive plans

Health plans

Life insurance

Disability

Flexible time off

Holiday shutdown

Paid holidays

Job summary

Ardelyx, a commercial-stage biopharmaceutical company, seeks an Associate Director of Quality Auditing & Compliance to lead a risk-based internal audit program and partner with leaders to ensure timely remediation of issues. The role supports inspection readiness and continuous improvement of the QMS.

The candidate will evaluate FDA and ICH compliance, drive CAPA activities, and promote a culture of quality and scientific rigor across functions.

Qualifications

• Experience leading GxP audits and compliance assessments in pharma/biotech.
• Strong knowledge of FDA regulations, ICH guidelines, and CAPA processes.
• Ability to assess complex issues, apply risk-based judgment, and drive remediation.
• Experience supporting regulatory inspections and inspection readiness.

Responsibilities

• Develop, maintain, and execute the annual risk-based internal audit program across GxP areas.
• Plan, lead, document audits, including onsite audits of internal, external, and vendor audits.
• Evaluate compliance with FDA regulations, ICH guidelines, and global requirements.
• Partner with stakeholders to develop CAPAs and monitor remediation.
• Identify trends and communicate findings to Quality leadership.
• Support regulatory inspection readiness and mock inspections.
• Provide guidance to cross-functional teams on quality compliance.

Skills

Quality Assurance

Quality Compliance

Auditing

FDA Regulations

ICH Guidelines

CAPA

Data Integrity

Regulatory Inspections

Communication

Stakeholder Influence

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

Ardelyx, a commercial-stage biopharmaceutical company, seeks an Associate Director of Quality Auditing & Compliance to lead a risk-based internal audit program and partner with leaders to ensure timely remediation of issues. The role supports inspection readiness and continuous improvement of the QMS.

The candidate will evaluate FDA and ICH compliance, drive CAPA activities, and promote a culture of quality and scientific rigor across functions.