Strategic Head of External Manufacturing 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

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.