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Executive Director, Quality Compliance

Ardelyx

Job Location:

Waltham, MA - USA

Yearly Salary: USD 267000 - 327000

Posted: 10 September 2026 (13 hours ago)

Application Deadline: 8 December 2026

Vacancies: 1 Vacancy

Job Summary

Description

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 companys 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 Companys 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.

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

Qualifications:

Bachelors 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%

The anticipated annualized base pay range for this full-time position is $267000 - $327000 Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors including years of relevant experience training qualifications and internal equity. The compensation package may also include an annual bonus target and equity awards subject to eligibility and other requirements.

Ardelyx also offers a robust benefits package to employees including a 401(k) plan with generous employer match 12 weeks of paid parental leave up to 12 weeks of living organ and bone marrow leave equity incentive plans health plans (medical prescription drug dental and vision) life insurance and disability flexible time off annual Winter Holiday shut down and at least 11 paid holidays.

Ardelyx is an equal opportunity employer.

We do not accept unsolicited resumes from search firms or recruiters or similar vendors. Any such unsolicited resume submitted to any employee or through Companys career site without a valid signed search agreement signed by Companys authorized representative will be deemed the property of the company and no fees will be paid in the event of a hire. Company will have the right to hire any such candidate at its discretion without any financial obligation or fee owed to the vendor. Any verbal or written communication with a Company employee outside of this process will not be considered a binding agreement.

Required Experience:

Director

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