Quality Director, Cell & Gene Therapies – Hybrid

Scorpion Therapeutics; Boston (MA); Hybrid; USD 190,000 - 250,000; Full time

Job summary

Scorpion Therapeutics in the Boston area seeks a Senior Director of Quality Operations to oversee quality for clinical and commercial cell and gene therapy products, with responsibility for external manufacturing oversight. You will shape quality strategy and ensure GMP compliance across partnerships.

You will lead regulatory readiness, coordinate audits, and manage relationships with CDMOs while mentoring the Quality Operations team and reporting to senior leadership.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field.
• 12+ years in Quality Operations with commercial biologics or advanced therapies.
• Director-level or Senior Director-level leadership experience.
• Deep GMP knowledge (FDA, EMA, ICH).
• Experience in virtual/outsourced manufacturing and global regulatory inspections.

Responsibilities

• Provide strategic and operational leadership for external manufacturing and testing oversight, ensuring GMP/regulatory compliance.
• Manage relationships with CDMOs, contract testing labs, and logistics providers.
• Oversee product release, lot disposition, deviations, CAPAs, change controls, and investigations.
• Lead inspection readiness, participate in regulatory audits, and support filings including post-approval changes.
• Drive quality systems improvements, compliance monitoring, and governance.
• Mentor and develop the Quality Operations team and advise senior leadership.

Skills

Leadership

GMP/Regulatory Knowledge

CDMO Management

Quality Systems

Regulatory Audits

Cross-functional Partnership

Education

Bachelor's in Life Sciences or Engineering

Tools

QMS (TrackWise)

Job description

Scorpion Therapeutics in the Boston area seeks a Senior Director of Quality Operations to oversee quality for clinical and commercial cell and gene therapy products, with responsibility for external manufacturing oversight. You will shape quality strategy and ensure GMP compliance across partnerships.

You will lead regulatory readiness, coordinate audits, and manage relationships with CDMOs while mentoring the Quality Operations team and reporting to senior leadership.