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Job #03508

About our client Our client is an internationally established cord blood bank. Based just west of Tampa, Florida, they boast a state-of-the-art lab facility on site, annual sales of over $17M and an experienced management team. This is an excellent opportunity for the right candidate to join their team. Position Location Director of Quality and Regulatory Affairs Florida Salary Highly competitive package, commensurate with experience Responsibilities 1) Serve as the company’s management representative for the strategic direction and overall management of the quality system for regulatory compliance. 2) Handle quality strategy for implementing the quality policy/plans by driving initiatives set in the 2-year business plan 3) Oversee the direction of quality within the organization 4) Keep abreast of all applicable licensure (federal/state) 5) Ensure compliance with all the accrediting bodies (FDA, AABB, AATB, etc.) 6) Report on quality systems to executive management 7) Ensure all products and services are in compliance with regulatory requirements 8) Anticipate and adapt the quality system to the changing global marketplace and intensified regulatory climate 9) Serve as the process lead for the quality manual 10) Define the quality policy for endorsement by executive management and serve as the quality system management rep 11) Develop strategic and tactical quality plans 12) Conduct quality system management reviews 13) Lead quality improvement 14) Provide motivation and leadership to meet goals set in the 2-year plan 15) Ensure regulatory compliance and CAPA, quality audits, document management as well as supplier qualification 16) Manage the complaint process 17) Approve product transfer under design control 18) Chart out quality training requirements for all company positions Requirements 1) Bachelor’s degree in Natural Sciences, Medical Technology, Engineering or a related area (advanced degree preferred) 2) Quality management and/or regulatory certifications (CQM, CQA, CQE, RAC, etc.) 3) 15 years of industry experience in a biologic, pharmaceutical and/or device manufacturing/development of which 5 years are in managing a quality/regulatory department 4) Experience as an internal auditor and managing external audits (ISO, FDA, AABB) 5) Proficient in the use of statistical analysis as a tool to maintaining and riving product quality 6) Excellent management skills in an technical disciplinary environment