Quality Assurance Manager

Role: Quality Assurance Manager overseeing QA support across pharmaceutical, biologics, and device manufacturing processes. Primary focus on ensuring compliance with regulatory standards (FDA, EMA, ICH) throughout product lifecycle from raw materials to final shipment. Responsibilities include developing quality policies, leading compliance assessments, managing deviations and CAPA processes, and interfacing with regulatory agencies during inspections. The role involves directing a team of professionals, translating strategic quality objectives into tactical plans, and maintaining expertise in GMP, GxP, and relevant regulations. Qualifications: Bachelor's in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or related field; 8+ years in QA, quality oversight, or relevant experience; leadership experience with technical teams; deep knowledge of QA systems, GMP, and regulatory requirements for pharmaceuticals, biologics, or medical devices. Preferred skills include cross-functional collaboration, project management, and strong communication abilities. The position requires experience in regulated manufacturing environments, with a focus on quality systems and compliance. Work setup details or travel expectations are not specified.