Associate Director, Quality Auditing & Compliance

Ardelyx•Waltham, MA

1d•Hybrid

About The Position

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients. Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive. We foster an inclusive environment where employees are respected, supported, and empowered to make an impact — both within our company and in the lives of patients we serve. This is hybrid role with 2-3 days per week onsite in our Waltham, MA or Newark, CA office. 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).

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.
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
Ability to operate independently, exercise sound judgment, and influence cross-functional stakeholders without direct authority
Ability to travel domestically and internationally 30 - 40%

Nice To Haves

Auditor certification or equivalent professional certification preferred

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