2 fraud analyst jobs found

Job Summary The Associate Director, Global Product Quality - GMP Process is responsible for enabling the optimization and harmonization of key GMP quality practices across the global organization. This role defines, maintains continuously improves critical quality system elements including Product Quality Complaints (PQC), Corrective and Preventive Actions (CAPA), Deviations, and Change Control , ensuring compliance with global regulatory requirements and internal standards. The successful candidate will lead cross-functional initiatives to enhance quality performance, reduce risk, and foster a culture of continuous improvement. Key Responsibilities Process Ownership & Governance:Lead the global strategy and governance for Product Quality Complaints, CAPA, Deviations, and Change Control processes. Develop and implement global standards, procedures, and best practices to ensure consistency and compliance across all global affiliates. Partner with regional and...

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. Job Description Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. Responsible...