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Job #03038

About our client Our client is the research and development division of a world-leading technology company that has developed a reputation for successfully bringing innovative drug delivery products to market. The company has an experienced management team, a stable history and a strong track record with the FDA. This is a strong opportunity for someone that wants to put their drive and initiative to work. Position Location Director of Quality Control Florida Salary Highly competitive package, commensurate with experience Responsibilities 1) Direct quality control labs and all activities associated with the quality testing of products 2) Provide technical direction to the QC staff and support all R&D activities related to product development and analytical development 3) Coordinate the transfer of analytical methods from other departments, partner companies, external clients or contract labs to the QC labs 4) Interface with business partners and CROs regarding quality issues 5) Maintain quality systems with the QC Department 6) Review managerial-level QC documentation, validation protocols and reports 7) Liaise with customers and provide QC responses during clients and/or regulatory audits 8) Schedule and track internal audit program 9) Coordinate and complete QC method transfers 10) Manage QC investigations and fully support product investigation as deemed necessary by the QA Department 11) Train staff and keep up-to-date on technical and regulatory compliance issues Requirements 1) BS from an accredited college or university 2) Minimum 10 years of pharmaceutical or directly related experience including 8 – 10 years of directed related supervisory expertise in a laboratory setting or equivalent combination of education and experience 3) Experience in data handling chromatographic systems 4) Experience in electronic records and electronic signatures 5) Experience in handling stability programs 6) Experience with transdermal delivery systems is highly desirable 7) Knowledge of quality systems and cGMP requirements 8) Ability to understand and balance the business needs versus scientific needs 9) Strong interpersonal skills to interface with many levels of an organization 10) Ability to maintain a friendly, cooperative and stable demeanor 11) Ability to manage several projects simultaneously and respond and adapt to project/task change based on business requirements 12) Excellent PC skills and knowledge of MS Office tools 13) Ability to perform tasks of substantial variety and complexity and to serve as a resource in the resolution of complex problems and issues 14) Good track record of motivating staff, coaching and mentoring 15) Strong leadership skills necessary to run the QC operation in sync with Manufacturing and ability to support the required volumes as per business plans