Associate Director, Quality Auditing & Compliance

About the role

Ardelyx, a commercial-stage biopharmaceutical company, is hiring an Associate Director, Quality Auditing & Compliance in Waltham, Massachusetts. The role leads the company's risk-based internal quality audit program, assessing compliance with GxP regulations, regulatory requirements, company policies and quality standards. It is a hybrid position with 2-3 days per week onsite in the Waltham, MA or Newark, CA office.

Key responsibilities

• Develop, maintain and execute the annual risk-based internal audit program across GxP areas and quality systems
• Plan, lead, document and perform audits, including onsite audits of internal, external and vendor/third-party audits
• Evaluate compliance with FDA regulations, ICH guidelines, global regulatory requirements, company procedures and industry standards
• Partner with functional stakeholders to develop CAPAs and monitor their timely closure
• Identify systemic trends and emerging compliance risks and share findings, metrics and recommendations with Quality leadership
• Support regulatory inspection readiness, mock inspections, health authority inspections and post-inspection remediation
• Advise cross-functional teams on quality compliance and help improve quality policies, procedures, audit methodologies, metrics and governance

Required profile

• Bachelor's degree, advanced degree preferred, in life sciences, pharmacy, engineering or a related field
• 8-10 years of progressive experience in QA, quality compliance, auditing or related functions in pharma or biotech
• Significant experience leading GxP audits and compliance assessments; experience across multiple GxP disciplines strongly preferred
• Experience supporting regulatory inspections and inspection-readiness activities
• Ability to travel domestically and internationally 30-40%

Required skills

• Strong knowledge of FDA regulations, ICH guidelines, quality systems, CAPA and data integrity
• Auditor certification or equivalent professional certification preferred
• Strong written and verbal communication, able to convey audit findings to senior leadership

What we offer

• Anticipated annualized base pay of $188,000-$230,000, possibly with an annual bonus target and equity awards
• 401(k) with employer match, 12 weeks of paid parental leave, equity incentive plans
• Health, dental, vision, life insurance and disability coverage
• Flexible time off, annual winter holiday shutdown and at least 11 paid holidays