Executive Director, Quality Compliance

Ardelyx, Inc.; Waltham (MA); Hybrid; USD 267,000 - 327,000; Full time

Benefits offered by this job

401(k) match

Parental leave

Organ/bone marrow leave

Equity incentives

Health plans

Life insurance

Flexible time off

Holidays

Job summary

Ardelyx, Inc. in Massachusetts is seeking an Executive Director, Quality Compliance to provide independent oversight of the global GxP framework.

You will lead the Quality Compliance team, shape risk-based programs, and partner with senior leadership to ensure regulatory readiness and ongoing compliance across the company and external partners. The role emphasizes audit strategy, regulatory inspection readiness, Quality Risk Management, and governance through the Quality Master Plan, with a

Qualifications

• 15+ years of progressive Quality or Compliance experience in biopharma.
• Experience leading Quality or Compliance teams in a commercial-stage organization.
• Strong knowledge of FDA, ICH, and global GxP expectations.

Responsibilities

• Lead and develop the Quality Compliance team and provide independent, risk-based oversight and assurance of global GxP compliance and Quality systems.
• 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
• 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
• Own and maintain the Quality Master Plan, translating Quality risks, regulatory expectations, and business priorities into strategic Quality initiatives

Skills

Leadership

Quality Compliance Leadership

Audit program management

Regulatory know-how

Executive communication

Cross-functional partnering

Risk management

Strategic thinking

Education

Bachelor’s degree in life sciences or related field

Advanced degree preferred

Job 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 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.

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:

• 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%
  

The anticipated annualized base pay range for this full-time position is $267,000 - $327,000 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

• 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
• 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 Company's career site without a valid, signed search agreement signed by Company's 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.