External Quality Operations Leader

Ardelyx, Inc.; Northern (KY); Hybrid; USD 267,000 - 327,000; Full time

Benefits offered by this job

401(k) with match

Paid parental leave

Equity awards

Job summary

Ardelyx is seeking an Executive Director, External Operations Quality to provide strategic and operational leadership for quality oversight of the company’s external manufacturing network, including CMOs, testing labs, packaging and labeling providers.

This senior leader ensures externally manufactured products meet quality standards and regulatory requirements while driving risk management and continuous improvement across external partners.

Qualifications

• Bachelor’s degree in life sciences, engineering, pharmacy, or related field with 15+ years in Quality/Compliance.
• Experience leading Quality or Compliance teams in a commercial-stage biotechnology/pharma company.
• Global regulatory knowledge including FDA and ICH.
• Proven ability to lead enterprise compliance programs and audits.

Responsibilities

• Lead Quality oversight and governance of CMOs, suppliers, service providers, and alliance partners.
• Serve as primary Quality contact for external partners, including escalation and performance monitoring.
• Lead development, negotiation, approval, and lifecycle management of Quality agreements.
• Oversee external change controls, deviations, investigations, and CAPAs.
• Provide Quality leadership for technology transfers and manufacturing readiness.
• Establish alliance partner QA governance and escalation pathways.
• Oversee APQRs including trend evaluation and follow-up actions.
• Provide strategic oversight of analytical and QC activities.
• Monitor external partner quality metrics and drive continuous improvement.
• Support partner selection, audits, inspections readiness.
• Identify and communicate risk to senior leadership and mitigation strategies.
• Lead and mentor External Operations Quality team.

Skills

Leadership

Quality management

Regulatory knowledge

Communication

Travel readiness

Education

Bachelor’s degree in life sciences, engineering, pharmacy, or related discipline

Advanced degree preferred

Job description

Ardelyx is seeking an Executive Director, External Operations Quality to provide strategic and operational leadership for quality oversight of the company’s external manufacturing network, including CMOs, testing labs, packaging and labeling providers.

This senior leader ensures externally manufactured products meet quality standards and regulatory requirements while driving risk management and continuous improvement across external partners.