Associate Director, GMP Quality—CGT & Personalized Medicine

Scorpion Therapeutics; Boston (MA); On-site; USD 148,000 - 222,000; Full time

Job summary

Scorpion Therapeutics is seeking a senior Quality leader to design and execute robust quality systems across programs. You will align QMS strategy with cross-functional teams to drive improvements and ensure regulatory compliance.

You will oversee APQR/QPQA, data integrity, change control, CAPA, and audits while guiding risk management and quality culture. Travel up to 15% may be required.

Qualifications

• Deep expertise in global GMP regulations/guidances and GxP QMS.
• 10+ years product lifecycle experience from discovery to commercial development.
• Strong leadership and cross-functional collaboration; excellent written and verbal communication.

Responsibilities

• Lead APQR and QPQA processes, ensuring on-time execution and regulatory alignment.
• Define DI program strategies; deploy locally with governance and drive DI improvements.
• Provide quality system oversight (change control, events, CAPA, escalation) and monitor QMS metrics.

Skills

GMP regulations

GxP QMS

Leadership

Cross-functional collaboration

Project management

Technical writing

Communication

CAPA

Root-cause analysis

Change control

Education

Bachelor's degree in science/related field

Job description

Scorpion Therapeutics is seeking a senior Quality leader to design and execute robust quality systems across programs. You will align QMS strategy with cross-functional teams to drive improvements and ensure regulatory compliance.

You will oversee APQR/QPQA, data integrity, change control, CAPA, and audits while guiding risk management and quality culture. Travel up to 15% may be required.