Hybrid Director, Cell & Gene Therapy Quality & Process

Scorpion Therapeutics

Boston (MA)

Hybrid

USD 180,000 - 280,000

Full time

5 days ago

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Job summary

Scorpion Therapeutics in Boston seeks a Director of Manufacturing Process & Technical Quality to oversee QA and compliance for Cell & Gene Therapies from development to post-approval. You will translate the quality strategy into operational plans and lead lifecycle quality activities.

This role requires deep GXP knowledge, experience across clinical to commercial stages, and strong leadership to coordinate with Development, Manufacturing, Regulatory, and external partners, including support for

Qualifications

Bachelor's degree in life sciences, biotech, or engineering.
10+ years in biotech/pharma quality, manufacturing, or technical operations.
At least 3 years of leadership experience.
Deep knowledge of global GXP regulations and cell/gene therapy tech (e.g., AAV).
Experience across clinical to commercial product life cycles.
Strong leadership, communication, and influencing skills.

Responsibilities

Translate quality strategy into operational plans to ensure GxP compliance.
Lead lifecycle quality activities from development through post-approval.
Ensure adherence to global GXP regulations and regulatory standards.
Support manufacturing readiness and risk management.
Collaborate cross-functionally with Development, Manufacturing, Regulatory, and external partners.
Support regulatory inspections and submissions.