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Director, Quality Management (GMP/QSR). Sept. 10, 2009
Otsuka
America Pharmaceutical, Inc. (OAPI) is seeking a Director, Quality
Management. OAPI headquartered in Rockville, Maryland, and Princeton,
NJ, is a successful, innovative, fast-growing healthcare company that
commercializes Otsuka-discovered and other product opportunities in
North America, with a strong focus on and commitment to neuroscience,
cardiovascular, oncologic, and gastrointestinal therapeutic treatments.
The Director, Quality Management will provide guidance and expertise to
OAPI in the interpretation and implementation of manufacturing and
quality system regulations applicable to investigational and commercial
products. In addition, he/she will ensure that SOPs describing internal
processes are developed and maintained and that the appropriate quality
audits are conducted and responded to in order to maintain compliance
with regulations and guidelines.
Key qualification requirements include: a Bachelor’s degree from
a four-year college or university; MBA or M.S. strongly preferred;
strong working knowledge of current Good Manufacturing Practice (cGMP)
and quality system regulations, audit techniques and government
regulatory inspection procedures; 10 – 15 years of experience in
a regulated industry environment, preferably in the global
pharmaceutical and/or medical device industry. Please send resume to
Steve Sellers at ssellers@andersonexecsearch.com or fax 704-347-0064.
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