Executive Director, Quality Compliance

Scorpion Therapeutics; Waltham (MA); Hybrid; USD 180,000 - 280,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Quality leader to oversee global GxP compliance and quality systems for a commercial-stage biopharma organization. The role emphasizes independent oversight, governance of quality frameworks, and ensuring inspection readiness to meet regulatory standards.

You will lead the Quality Compliance team, manage audits, and drive inspection preparedness, risk management, and incident reporting metrics across the enterprise.

Qualifications

• Bachelor's degree in life sciences or related field.
• 15+ years in GxP quality/compliance within biotech or pharma.
• Proven leadership in global compliance programs.
• Strong knowledge of FDA, ICH, and international standards.
• Experience with external manufacturing and regulatory interactions.

Responsibilities

• lead the Quality Compliance team
• manage risk-based audits (internal, external, third-party)
• oversee inspection preparedness
• manage Quality Risk Management
• govern Quality incident reporting and metrics

Job description

Role

Senior Quality leader overseeing global GxP compliance and quality systems at a commercial-stage biopharma company.

Objectives

provide independent oversight, assurance, and governance of quality frameworks, ensuring inspection readiness and regulatory compliance.

Responsibilities

• lead the Quality Compliance team


• manage risk-based audits (internal, external, third-party)


• oversee inspection preparedness


• manage Quality Risk Management


• govern Quality incident reporting and metrics

Qualifications

• Bachelor's in life sciences or related;


• 15+ years in GxP quality/compliance within biotech or pharma;


• proven leadership in global compliance programs;


• strong knowledge of FDA, ICH, and international standards;


• experience with external manufacturing and regulatory interactions

HighValue

• extensive GxP expertise;


• global audit and inspection oversight;


• risk management;


• leadership in commercial biopharma;


• ability to operate across external partners

WorkSetup

hybrid Waltham, MA with up to 30% travel.