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 Senior Quality Specialist level is considered to be a position of increased responsibility within the Global Quality Management function. In this role, the Sr. Quality Specialist will be responsible for the GCP and/or GVP auditing internal and external entities. In addition, this role will represent CQM as a member of a Study Team and/or Otsuka and Global Quality initiatives, independently providing GCP guidance while supporting Inspection Readiness visits.
This role may also support Quality operations within the Global Quality Management group; potentially as a Subject Matter Expert (SME), who will be responsible for driving the management of assigned activities within the group. This could include SOP Management, CAPA Management, Deviation Management, SOP/GxP related Training and Inspection Readiness and support in addition to other assigned Quality tasks.
Education & Related Experience