- United States
- Full-time · Director
- $230K–$270K per year
- 10+ years
Seeking a strategic leader to serve as Head of Quality Assurance to lead quality strategy and management systems through launch and early commercialization in the US. Overseeing GxP activities across manufacturing, supply chain, distribution, quality systems, and vendor management.
Compensation
The expected salary range for this position is $230,000.00 - $270,000.00 USD.
Responsibilities
- Build and maintain a scalable quality management system (QMS) that evolves from clinical-stage to commercial-readiness, ensuring compliance with FDA, ICH, and global GxP standards.
- Anticipate factors that could influence the company's quality strategy and market position, providing strategic direction across functional areas.
- Establish and oversee robust commercial quality processes, including final product release/disposition, supply chain security, and distribution quality.
- Provide quality oversight for GLP, GCP, and GMP vendors; lead vendor qualifications, perform audits, and manage quality agreements with contract manufacturing and research organizations.
- Lead the management of deviations, CAPAs, change controls, and quality investigations, ensuring timely resolution and implementation of effective corrective actions.
Requirements
- Bachelor of Science degree in a life science discipline (biology, chemistry, etc.)
- Nice to have: Advanced degree
- Nice to have: EMA regulations
- Nice to have: APAC regulations