QA IT Lead

This is Contract-to-hire role in NYC. Client is not providing sponsorship.

We are seeking an experienced IT QA professional with a strong background in pharmaceutical manufacturing, specifically with a minimum of 7 years operating in a GxP-regulated environment. This position is focused on Quality Assurance and Data Integrity support it is not a software tester or validation engineer role.

The ideal candidate will be responsible for shaping and enforcing IT quality policies and procedures that align with FDA regulations, GxP compliance standards, and internal SOPs and CAPA processes. Prior experience supporting IT quality initiatives related to infrastructure (servers, systems) and enterprise applications is crucial.

We are looking for someone who has worked closely with manufacturing or lab operations, particularly in the context of QA investigations, CAPAs, and deviation handling. The role also involves oversight of periodic reviews such as service/user account monitoring and evaluations of IT systems for compliance and performance.

Candidates with a history of addressing IT system-related deviations and who have contributed to the development and implementation of CAPA plans are strongly preferred. Please be prepared to discuss which systems you ve supported and your involvement in associated investigations.