Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is an innovative, fast-growing healthcare company that discovers and develops new compounds that address unanswered medical needs and advance human health. With a strong focus on neuroscience, oncology, and cardio-renal treatments, OPDC is dedicated to improving the health and quality of human life. For more information, visit www.otsuka-us.com.
OPDC is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en/.
The Manager of Global Quality Systems Auditor will provide leadership, expert advice, and hands on capabilities to various types of audits that includes, but not limited to, supplier audits, computerized systems audit, and data integrity audit for regulated pharmaceutical industry. Primary responsibilities will be manager contributions for all audit activities risk-based computerized systems validation internal and third party supplier audit plan, including CAPA reviews and approvals, computerized system validation audit metrics management, and vendor management. This role also will provide support for assigned Global Quality Systems operational responsibilities, such as the audit budget and intelligence sharing.