Sterility Assurance Lead

The Sterility Assurance Lead is responsible for leading and maintaining site-wide sterility assurance and contamination control programs within a sterile pharmaceutical manufacturing environment. This role provides technical leadership and oversight for terminally sterilized and injectable drug product operations, ensuring compliance with FDA aseptic processing guidance, EU Annex 1, cGMP standards, and global regulatory requirements. The position serves as the site Subject Matter Expert (SME) for sterility assurance, environmental monitoring, microbiological risk management, and contamination control strategies while supporting process validation, regulatory inspections, and continuous improvement initiatives.

**Location: Raleigh NC**
**Salary: $90,000-$110,000/year**
**Direct Hire role**
**No relocation assistance offered**

**Key Responsibilities**

**Sterility Assurance & Contamination Control**


+ Develop, implement, and maintain steril...