Executive Director, Quality 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 office. Position Summary: The Executive Director, Quality Compliance is a senior Quality leader responsible for providing independent oversight, assurance, and governance of the company’s global GxP compliance framework. Reporting to the SVP, Head of Global Quality, this role provides objective assessment of the effectiveness, maturity, and sustainability of the Company’s Quality systems and compliance practices. This role establishes and maintains an integrated, risk-based approach to compliance oversight across the organization and its external partner network. Key areas of accountability include audits, inspection readiness, Quality Risk Management, Quality incident and escalation management, management review and Quality Council governance, and the Quality Master Plan.

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.

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.