Vice President, Quality

Vice President, Quality

KV Pharmaceutical Company (KV), a NYSE listed specialty pharmaceutical company headquartered in St. Louis, MO, is a unique specialty pharmaceutical company that has prowess in drug delivery technology.  We have a proven track record competing in both the branded market (Ther-Rx), and generic and non-branded market (ETHEX).  With nearly one million square feet of state-of-the-art manufacturing and distribution space, we have been listed numerous times among Forbes 200 Fastest Growing Companies in the U.S.

Position Overview:

KV Pharmaceutical is seeking an experienced Vice President to head our Quality Departments. As the VP of Quality, you will reports to Chief Executive Officer (CEO) of KV and will be responsible for all Quality Assurance and Quality Control functions at all of our facilities ensuring appropriate quality standards are met prior to the shipment of our products.  You will also be responsible to ensure all operations are in compliance with cGMP guidelines, including third party vendors and partners. In addition, you will be a member of the Executive Committee as well as the Quality Counsel, and therefore, will be involved in the strategic direction and overall management of the organization.  

Essential Functions

• Direct the development, implementation, and maintenance of a comprehensive written QA and QC Program to ensure that all drug products manufactured, processed, packed, and distributed by the Company, including any produced by third party, meet all safety and quality standards and potency that they are represented to possess.


• Provide technical expertise and recommendations to the CEO, Executive Committee, Board of Directors, and as appropriate to others in Company on day-to-day quality and compliance issues.


• Provides formal quarterly updates on the status of the Company’s quality and compliance programs to the Board of Directors and CEO.


• Develop and assist business in implementation of appropriate compliance systems and programs working closely with the: Chief Compliance Officer, VP, Consent Decree, VP of Operations, VP of Human Resources, CFO, and the CEO.


• Provides oversight to R&D to assure that the Company uses sound scientific product development and design practices with an emphasis on Quality by Design.


• Represents the Company during site visits by the FDA, DEA and key customer visits.  Responds or reviews drafted responses to all 483s or customer audits and ensures all observations are corrected or addressed in a timely manner.


• Monitors and directs the completion of all formal commitments to the FDA, EPA, DEA, ATF, OSHA, or other regulatory bodies.  Establishes and maintains a system for collecting and controlling the implementation of all commitments, making use of other department resources as needed. 


• Reviews all investigations of issues involving quality problems conducted by QA staff.  Provides support as needed to supervisors to ensure appropriate corrective actions are taken in a timely manner. 


• Monitors the implementation and verification of corrective actions to prevent future occurrence of NCR’s and deviations


• Represents, the QA & QC functions of the Company to the pharmaceutical industry and government agencies for the purpose of promoting the Company’s interests.  Maintains membership in appropriate organizations, attends meetings, seminars and presentations.

Qualifications:

Candidate Profile:

• Self-motivated individual with a desire to help drive highest quality standards and build a quality oriented culture.


• Intimate knowledge of cGMPs and other pharmaceutical industry regulations and requirements.


• Proven track record of directly and effectively interfacing with FDA, DEA, ATF, customers and vendor representatives at various levels.


• Excellent critical thinking and problem solving skills.


• Capable of managing large staff of diverse scientific personnel.


• Results-oriented and adaptable; can act independently in their area of responsibility.


• Effective communicator – ability to write clearly and to support a point, and ability to provide concise verbal summaries to management


• Superior oral presentation skills.


• Organized individual who can handle multiple programs and priorities simultaneously.


• Needs high ethical standards, good judgment, and maturity.

Education/Experience:

• Bachelor’s degree in Chemistry, Pharmacy or other science. Advanced degree a plus.


• 15 years of progressive experience directing and managing broad range of QA, QC, and validation programs in a reputable pharmaceutical company.


• 5 years of experience serving as a member of executive management team with significant interface with CEO and Board of Directors on quality matters.


• 5 years of experience interfacing directly with the FDA, DEA and other regulatory agencies/bodies.

COMPANY OVERVIEW

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.

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 will provide a competitive compensation package in addition to a comprehensive benefits package including a 401(k) and profit-sharing, health, vision, and dental.

KV Pharmaceutical is an Equal Opportunity Employer. M/F/D/V