Job Description
KV Pharmaceutical is seeking an Director, Quality Assurance Operations. The successful candidate will be responsible for the quality assurance and cGMP compliance activities for all the manufacturing sites, warehousing/distribution systems, companywide label control, and other duties assigned by the Vice President of QA. You will also provide support for identifying and achieving key company, Operations, and departmental strategies, tactics, and objectives relating to product quality and cGMP compliance.
The Director will direct the NCR follow-up and completion including the final approval of all deviations and NCR’s prior to Batch Release, change control, process and cleaning validation. You will also have responsibility to insure that QA personnel being continuously trained, motivated, provided development /improvement/ growth opportunities on a continual basis.
The successful candidate will have the following skills/abilities: understanding of the overall business needs and objectives, including Sales, Marketing, Manufacturing, etc; demonstrate expertise utilizing contemporary tools to meet current and advancing cGMP requirement; direct experience hosting and leading in the preparation, management, and follow-up relating to FDA inspections. A minimum of 10 years of experience in a QA/QC pharmaceutical operational role with 5 years of leading QA units is required. It is preferred that the Associate Director have a BA or BS in related technical Field (Chemistry, Pharmacy etc), prior experience at one or more other “large-pharma” firm. Also preferred: Certified Quality Engineer (ASQ) status, authorship of cGMP articles in peer-reviewed journals, previous presentations at national or international conferences/seminars.
We are seeking individuals who possess excellent verbal and written communication skills, offers an organized approach to providing timely accurate reports, can multi-task, prioritize, and are self motivated with the ability to be effective with minimum supervision.
With 13 years of record revenues, KV Pharmaceutical Company (www.kvph.com), a high-growth organization, has reported year-over-year net sales of 35.7% to over $600 million for Fiscal Year 2008.
KV Pharmaceutical (NYSE: KVa/KVb), is a fully integrated specialty pharmaceutical company that develops, manufactures, markets and acquires technology-distinguished branded and generic/non-branded prescription pharmaceutical products. The Company markets its technology-distinguished products through ETHEX Corporation, a national leader in pharmaceuticals that compete with branded products, and Ther-Rx Corporation, its emerging branded drug subsidiary. With more than 65 years in business, KV applies its 15 unique patent protected and proprietary drug delivery technologies to both the brand and generic/non-branded products.
KV is based in St. Louis, Missouri, which was recently named as a 2008 All-America City by the American City Business Journals, one of Forbes’ “200 Best Metropolitan Areas” in America in 2006. St. Louis was also named the second most affordable large metropolitan area in the country by the National Association of Home Builders in 2005.
St. Louis offers a world-class medical community with over 50 general practice, teaching and research hospitals including Washington University and St. Louis University. St. Louis is also rich in education with more than a dozen nationally-recognized four-year universities.
KV Pharmaceutical provides a comprehensive benefits package including a 401(k) and profit-sharing, health, vision, and dental. We offer competitive salaries and stock options for many positions which have proven to be lucrative to many long-term KV employees.
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