Executive Director, External Operations Quality

Scorpion Therapeutics; Waltham (MA); Hybrid; USD 190,000 - 260,000; Full time

Job summary

Ardelyx seeks an Executive Director, External Operations Quality to provide strategic and operational leadership for the quality oversight of the external manufacturing network, including CMOs, testing labs, and packaging partners.

You will oversee governance, escalations, risk management, and CAPAs, while supporting technology transfers and regulatory inspections. A senior leader with deep GxP and global regulatory experience is required.

Qualifications

• Bachelor's in life sciences, engineering, pharmacy, or related field.
• 15+ years in GxP quality or compliance within biotech/pharma.
• Significant leadership in commercial-stage organizations.
• Deep knowledge of global GxP regulations, FDA, ICH, and international standards.
• Experience managing external manufacturing compliance, audits, and risk.

Responsibilities

• Oversee compliance, product quality, and supply reliability across CMOs, testing labs, and packaging partners.
• Lead quality governance, issue escalation, performance monitoring, and risk management.
• Manage quality agreements, change controls, investigations, and CAPAs.
• Support technology transfers, validation, and regulatory inspections.
• Monitor quality metrics and continuous improvement initiatives.

Skills

GxP quality

Compliance

Leadership

Regulatory knowledge

Education

Bachelor's in life sciences, engineering, pharmacy, or related field

Job description

Role: Executive Director, External Operations Quality, providing strategic and operational leadership for quality oversight of Ardelyx’s external manufacturing network.

Responsibilities:

• oversee compliance, product quality, and supply reliability across CMOs, testing labs, and packaging partners
• lead quality governance, issue escalation, performance monitoring, and risk management
• manage quality agreements, change controls, investigations, and CAPAs
• support technology transfers, validation, and regulatory inspections
• monitor quality metrics and continuous improvement initiatives.

Requirements:

• Bachelor's in life sciences, engineering, pharmacy, or related field
• 15+ years in GxP quality or compliance within biotech/pharma
• significant leadership in commercial-stage organizations
• deep knowledge of global GxP regulations, FDA, ICH, and international standards
• experience managing external manufacturing compliance, audits, and risk.

Preferred:

• experience in biopharma quality leadership, global compliance programs, and managing quality for biologics or other modalities.

High-Value:

• extensive external partner oversight, manufacturing quality governance, regulatory inspection readiness, and global GxP expertise.

WorkSetup:

hybrid (Waltham, MA or Newark, CA), with up to 25% domestic and international travel.