This position will function as the QA-designated subject matter expert (SME) for development and commercial products. Perform and/or manage QA activities related to development and commercial product compliance and operations.
Duties will include: Assurance of development and commercial product quality, oversight of changes, exceptions, product disposition, audits/inspections, complaints and timely and meaningful resolution of potential Quality issues.
Stay abreast of current regulatory trends and changes, including GLP and GMP.
Assure compliance of agreements with CMOs and CTLs, specifically, compliance with both company and regulatory standards. Manage CMO’s and CTL’s to ensure compliance with the terms of agreements.