Summary

The Associate Director, Quality Auditing & Compliance is responsible for leading and executing the company’s risk-based internal Quality audit program to assess compliance with applicable GxP regulations, regulatory requirements, company policies, and Quality standards. This role provides an independent, objective assessment of Quality System effectiveness, identifies and evaluates compliance risks and improvement opportunities, and partners with functional leaders to ensure timely and sustainable remediation of identified issues. The position serves as a senior Quality Compliance subject matter expert and supports organizational inspection readiness, regulatory intelligence, and continuous improvement of the Quality Management System (QMS).

Job description

Position Summary

The Associate Director, Quality Auditing & Compliance is responsible for leading and executing the company’s risk-based internal Quality audit program to assess compliance with applicable GxP regulations, regulatory requirements, company policies, and Quality standards. This role provides an independent, objective assessment of Quality System effectiveness, identifies and evaluates compliance risks and improvement opportunities, and partners with functional leaders to ensure timely and sustainable remediation of identified issues. The position serves as a senior Quality Compliance subject matter expert and supports organizational inspection readiness, regulatory intelligence, and continuous improvement of the Quality Management System (QMS).

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. This includes onsite audits of internal, external, and vendor/third-party audits
Evaluate compliance with applicable FDA regulations, ICH guidelines, global regulatory requirements, company procedures, and established industry standards
Partner with functional stakeholders to develop appropriate corrective and preventive actions (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

Requirements

Bachelor’s degree, advanced degree preferred, in life sciences, pharmacy, engineering, or a related discipline
8 – 10 years of progressive experience in Quality Assurance, Quality Compliance, auditing, or related functions within the pharmaceutical or biotechnology industry or equivalent experience
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
Demonstrated ability to independently assess complex compliance issues, apply risk-based judgment, and influence effective remediation
Experience supporting regulatory inspections and organizational inspection-readiness activities
Strong written and verbal communication skills, including the ability to communicate audit findings and compliance risks effectively to senior leadership
Auditor certification or equivalent professional certification preferred
Ability to operate independently, exercise sound judgment, and influence cross-functional stakeholders without direct authority
Ability to travel domestically and internationally 30 - 40%

Benefits

401(k) plan
Paid parental leave
Living organ and bone marrow leave
Equity incentive plans
Health plans
Life insurance
Disability insurance
Flexible time off
Winter holiday shut down
Paid holidays

Company overview

Ardelyx, Inc. is a biopharmaceutical company founded in 2007 and headquartered in Fremont, California, with additional offices in Waltham, Massachusetts. The company specializes in discovering, developing, and commercializing innovative, first-in-class medicines that address significant unmet medical needs. Ardelyx has developed a unique platform that enables the discovery of novel biological mechanisms and pathways to create potent and efficacious therapies while minimizing side effects and drug-drug interactions commonly associated with traditional systemically absorbed medicines. The company currently has two FDA-approved commercial products: IBSRELA® (tenapanor) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C), and XPHOZAH® (tenapanor) for reducing serum phosphorus in adults with chronic kidney disease on dialysis. Ardelyx has established strategic partnerships for international commercialization, including agreements with Kyowa Kirin in Japan and Fosun Pharma in China. As a publicly traded company on NASDAQ under the symbol ARDX, Ardelyx employs approximately 201-500 professionals and continues to advance its pipeline of gastrointestinal and renal disease therapeutics.