Senior Quality Audit & Compliance Lead (Hybrid)

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

Benefits offered by this job

401(k) plan with generous employer mix

12 weeks of paid parental leave

Living organ and bone marrow leave

Job summary

Ardelyx is seeking an Associate Director, Quality Auditing & Compliance to lead its risk-based internal audit program and ensure GxP compliance across the organization. This hybrid role supports regulatory readiness and continuous improvement of the QMS.

The role requires 2-3 days onsite per week at the Newark, CA or Waltham, MA offices, with 30-40% travel. You will partner with cross-functional teams to drive CAPAs and strengthen quality culture across Ardelyx.

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; experience across multiple GxP disciplines strongly preferred
• Strong knowledge of FDA regulations, ICH guidelines, Quality Systems, CAPA, data integrity, and applicable global regulatory requirements
• 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, ensuring clear identification and communication of observations and compliance risks
• Evaluate compliance with applicable FDA regulations, ICH guidelines, global regulatory requirements, company procedures, and established industry standards
• Partner with functional stakeholders to develop appropriate CAPAs and monitor remediation through timely and effective closure
• Identify systemic trends and emerging compliance risks and communicate significant findings, metrics, and recommendations to Quality leadership
• Support regulatory inspection readiness, mock inspections, health authority inspections, and post-inspection remediation activities
• Provide Quality Compliance guidance to cross-functional teams and promote a culture of Quality, accountability, scientific rigor, and continuous improvement
• Contribute to the development and improvement of Quality policies, procedures, audit methodologies, compliance metrics, and governance processes
• Maintain current knowledge of evolving regulatory expectations and industry practices and assess their potential impact on the organization

Skills

Quality auditing

Regulatory compliance

Risk assessment

Communication

Leadership

Education

Bachelor's degree in life sciences or related field

Advanced degree preferred

Tools

Audit management software

Quality Management System (QMS)

Job description

Ardelyx is seeking an Associate Director, Quality Auditing & Compliance to lead its risk-based internal audit program and ensure GxP compliance across the organization. This hybrid role supports regulatory readiness and continuous improvement of the QMS.

The role requires 2-3 days onsite per week at the Newark, CA or Waltham, MA offices, with 30-40% travel. You will partner with cross-functional teams to drive CAPAs and strengthen quality culture across Ardelyx.