Executive Director, Quality Compliance

Ardelyx•Waltham, MA

2d•$267,000 - $327,000•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 office

Requirements

Bachelor’s degree, advanced degree preferred, in life sciences, engineering, pharmacy, or related discipline with 15+ years of progressive Quality, Compliance, or related GxP experience in the biotechnology or pharmaceutical industry, or equivalent experience
Significant leadership experience in a commercial-stage organization
Demonstrated experience building, leading, and developing high-performing Quality or Compliance teams
Demonstrated leadership of global or enterprise compliance programs, including audits, regulatory inspection readiness, Quality Risk Management, and Quality governance
Strong knowledge of global GxP regulations and expectations, including FDA requirements and relevant ICH and international standards
Experience with Quality escalation management and health authority interactions
Proven ability to identify and synthesize complex Quality and compliance risks and communicate clear, actionable recommendations to senior and executive leadership
Strong executive presence, judgment, and influencing skills, with the ability to maintain independent Quality oversight while building effective cross-functional partnerships
Experience operating within a commercial biopharmaceutical organization and overseeing compliance across external manufacturers, laboratories, suppliers, and other GxP partners
Demonstrated ability to set strategic direction, establish priorities, manage resources, and lead through organizational and business change
Excellent written, verbal, analytical, organizational, and leadership skills
Ability to travel domestically and internationally up to 30%

Responsibilities

Lead and develop the Quality Compliance team and provide independent, risk-based oversight and assurance of global GxP compliance and Quality systems. Establish priorities, allocate resources, and ensure effective execution of the compliance strategy and objectives
Lead the global risk-based audit program, including internal, external, and vendor/third-party audits
Oversee audit strategy, execution, findings, remediation, and trend analysis
Lead enterprise inspection readiness and regulatory inspection support, including preparedness assessments, mock inspections, response strategy, and post-inspection commitments and remediation
Oversee the Quality Risk Management framework and monitoring of evolving regulatory requirements and guidance, ensuring appropriate impact assessment, escalation, and action
Provide governance and oversight for Quality incidents, including escalation and health authority reporting
Lead Quality Management Review and Quality Council governance, including reporting of Quality metrics, trends, risks, and overall compliance health to senior leadership
Own and maintain the Quality Master Plan, translating Quality risks, regulatory expectations, and business priorities into strategic Quality initiatives and monitoring execution and effectiveness