Sr. Specialist, External Quality Operations

Overview

Title: Sr. Specialist, External Quality Operations

Description of Position: Our biotech client is seeking a Sr. Specialist in the Quality Assurance (QA) department reporting to the Sr. Director of External Quality Operations. This position will be responsible for ensuring quality of cGMP activities at external contract organizations (CxOs) for aseptically produced investigational cell and gene therapy products. This position will work with a diverse group of internal and external partners.

Responsibilities

• Lead cGMP QA compliance activities at external CxOs for all relevant operations, including raw material testing, GMP manufacturing, QC testing, release, stability, packaging/labeling, lot disposition and clinical supply activities for aseptically produced investigational cell and gene therapy products
• Oversee quality aspects for technology Transfer, commissioning, qualification and validation activities for ...