Otsuka Pharmaceutical Companies (U.S.)
Harrisburg, PA, USA
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...
