Global Head of External Quality Operations

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

Benefits offered by this job

401(k) plan

Parental leave

Organ and bone marrow leave

Equity incentive plans

Health plans

Life insurance

Disability coverage

Flexible time off

Winter holiday shut down

Paid holidays

Job summary

Ardelyx seeks an Executive Director, External Operations Quality to provide strategic and operational leadership for quality oversight of the company’s external manufacturing network. You will partner with Manufacturing, Regulatory, and Supply Chain to ensure products meet quality standards and regulatory requirements.

The role requires extensive experience in commercial-stage biopharma, managing external partners, and leading QA governance across the network.

Qualifications

• Bachelor's degree in life sciences or related field; 15+ years in Quality/Compliance within biotech/pharma.
• Significant leadership experience in a commercial-stage organization.
• Experience building and leading high-performing Quality/Compliance teams.
• Global GxP knowledge, audits, regulatory inspections, and risk management.

Responsibilities

• Lead QA governance for CMOs, suppliers, and external partners to ensure compliance and quality.
• Serve as primary Quality contact for external partners with escalation and performance monitoring.
• Oversee quality agreements lifecycle and external change controls, deviations, investigations, and CAPAs.
• Provide QA leadership for technology transfers, method transfers, validation activities, and manufacturing readiness.
• Monitor external partner quality metrics and drive continuous improvement.

Skills

Quality leadership

External QA governance

Regulatory knowledge

Risk management

Cross-functional collaboration

Mentoring

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

Ardelyx seeks an Executive Director, External Operations Quality to provide strategic and operational leadership for quality oversight of the company’s external manufacturing network. You will partner with Manufacturing, Regulatory, and Supply Chain to ensure products meet quality standards and regulatory requirements.

The role requires extensive experience in commercial-stage biopharma, managing external partners, and leading QA governance across the network.