Global Quality Compliance Executive Leader

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

Benefits offered by this job

401(k) plan with generous employer-m…

Paid parental leave (12 weeks)

Living organ and bone marrow leave (12

Equity incentive plans

Health plans (medical, prescription,…

Life insurance and disability

Flexible time off

Winter Holiday shutdown

11 paid holidays

Job summary

Ardelyx, a commercial-stage biopharmaceutical company, seeks an Executive Director, Quality Compliance in a hybrid role based in Waltham, MA. This senior leader will oversee global GxP compliance, audits, inspection readiness, and Quality governance across the organization and partners.

You will drive risk-based oversight, lead the Quality Compliance team, and partner with senior leadership to ensure the effectiveness of Quality systems and regulatory readiness.

Qualifications

• Bachelor's degree or higher in life sciences, engineering, pharmacy, or related field with 15+ years in Quality/Compliance/GxP.
• Experience leading in a commercial-stage biopharma environment.
• Proven ability to build and lead high-performing Quality/Compliance teams.
• Experience managing global or enterprise GxP programs, audits, and regulatory interactions.

Responsibilities

• Lead and develop the Quality Compliance team and provide independent, risk-based oversight of global GxP compliance.
• Lead the global risk-based audit program, including internal, external, and vendor audits.
• Oversee audit strategy, findings, remediation, and trend analysis.
• Lead enterprise inspection readiness and regulatory inspection support, including mock inspections and post-inspection remediation.
• Oversee the Quality Risk Management framework and regulatory requirement tracking.
• Provide governance for Quality incidents and regulatory reporting.
• Lead Quality Management Review and Quality Council governance, reporting metrics, risks and compliance health to senior leadership.
• Own and maintain the Quality Master Plan and translate risks into strategic quality initiatives.

Skills

Leadership experience

Executive presence

Strategic thinking

Cross-functional leadership

Communication skills

Travel readiness

Change management

Problem solving

Influencing

Education

Bachelor's degree

Advanced degree preferred

Job description

Ardelyx, a commercial-stage biopharmaceutical company, seeks an Executive Director, Quality Compliance in a hybrid role based in Waltham, MA. This senior leader will oversee global GxP compliance, audits, inspection readiness, and Quality governance across the organization and partners.

You will drive risk-based oversight, lead the Quality Compliance team, and partner with senior leadership to ensure the effectiveness of Quality systems and regulatory readiness.