Sr Director, Quality Assurance - CMC

Company Name

Insmed Incorporated

Job Overview

The Sr. Director CMC QA leads Quality Assurance CMC oversight for drug products, biologics, and combination products from toxicology through Phase 3. This role ensures phase-appropriate GMP compliance in manufacturing development, provides strategic quality leadership to internal teams and external partners, and oversees QA support for development-stage activities.

Responsibilities

• Reviewing deviations
• Managing CAPAs and change controls
• Collaborating cross-functionally
• Managing CDMOs
• Leading quality agreements and audits

Requirements

• BS degree (advanced degree preferred) in a relevant science/engineering field
• 15+ years of biopharmaceutical QA experience (10+ in development)
• 7+ years GxP experience
• Strong knowledge of quality systems and regulatory requirements
• Leadership experience is essential