Senior Director, Quality Assurance
Humacyte
Full-time
Remote friendly (Durham, NC)
Worldwide
Operations
Senior Director, Quality Assurance
Company: Humacyte
Job Description
The Senior Director, Quality Assurance (QA) provides strategic direction and oversight for Humacyte's Quality Management System (QMS), ensuring compliance with global regulatory requirements (FDA, EMA, ICH). This leadership role manages QA teams supporting GxP operations (GMP, GLP, GCP), overseeing quality systems like CAPA, deviations, change control, and risk management.
Responsibilities
- Ensure inspection readiness
- Provide QA oversight for manufacturing
- Oversee packaging, labeling, testing, release, and distribution of products
Requirements
- 15+ years of QA leadership experience in biotechnology
- Strong knowledge of cGxP standards