Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		Job #07262 About our client Our client is a Fortune 500 provider of laboratory testing services. The company has a world class management team, a strong reputation with their customers and an exceptional track record of financial performance. This is a unique opportunity for an experienced executive that wants to put their drive and initiative to work! Position Location Executive Director, Quality and Compliance CA - South Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee quality systems and compliance with applicable FDA and ISO regulations as well as other state/international quality regulations by the company’s in vitro diagnostics business 2) Handle major corporate agreements as they relate to the quality systems within the IVD business units 3) Act as the main contact between the Corporate Compliance Officer and independent review organizations to ensure the completion of work plan 4) Oversee standardization and continuous improvement throughout the IVD business units 5) Serve as the point of contact for the independent review organizations 6) Oversee the compliance of the quality systems regulations at the IVD business units 7) Develop the work plans per the IRO request at the various US-based IVD sites and ensure compliance to the work plans 8) Provide regular updates to the CCO and senior management 9) Ensure that all activities, such as the annual GMP training and self certification for existing as well as new employees at the US-based IVD sites are completed on time per major corporate agreements 10) Serve on the Quality Council and provide regular updates to senior management on the quality scorecard 11) Advise senior management staff of trends and actions that must be incorporated into business and strategic planning 12) Perform assigned tasks in accordance with applicable safety regulations and instructions 13) Correct unsafe work habits and practices and/or bring to the attention of the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the employees 14) Set policy and oversee the activities of the various IVD sites as it relates to quality and compliance to QSR and ISO regulations or other regulations 15) Work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors 16) Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results 17) Ensure schedules are met 18) Interact regularly with senior management on matters concerning several functional areas, divisions and/or customers Requirements 1) Master’s degree in Science or equivalent 2) Minimum 10 years experience in all aspects of medical device or healthcare industry (IVD preferred) 3) Past executive-level (VP/Director) experience for quality and compliance with a leading company 4) Ability to change thinking or gain acceptance of others in sensitive situations 5) Ability to work with limited supervision and be detail-oriented 6) Ability to analyze and interpret common scientific and technical journals, financial reports and legal documents 7) Ability to respond to common inquires or complaints from customers, regulatory agencies or members of the business community 8) Ability to write speeches and articles for publication that conforms to prescribed style and format 9) Ability to effectively present information to top management, public groups, and/or boards of directors
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