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Job #03516

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 California Salary Highly competitive package, commensurate with experience Responsibilities 1) Responsible for the oversight of Quality Systems and compliance with applicable FDA and ISO regulations as well as other related state and international Quality regulations by the company’s Invitro Diagnostics business 2) This position will oversee major Corporate Agreements as they relate to the Quality Systems within the IVD business units and be the main contact between the Corporate Compliance Officer and Independent Review Organizations to ensure the completion of the work plan 3) This position sits on the company Quality Council to oversee the standardization and continuous improvement through out the IVD business units 4) Oversee the compliance of the Quality Systems Regulations at the IVD business units. 5) Operates as the point of contact for the Independent Review Organizations. Co-develops the work plans per the IRO request at the various US-based IVD sites and ensures compliance to the work plans. Additionally, provides regular updates to the CCO and Senior Management. Finally, ensures 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 6) Serves on the Quality Council and provides regular updates to Senior Management on the Quality Scorecard 7) Advises senior management staff of trends and actions that must be incorporated into business and strategic planning 8) Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing 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. Violations of safety directives and procedures will be handled in accordance with the established Company disciplinary process 9) Sets 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, where necessary. The Sr. Directors of multiple key business units will be dotted line into this position Requirements 1) Requires a Masters degree in Science or equivalent to include a minimum 10 years experience in all aspects of Medical Device or Healthcare Industry – IVD experience strongly preferred 2) Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors 3) Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensure schedules are met 4) Regularly interacts with senior management on matters concerning several functional areas, divisions, and/or customers 5) Requires the ability to change the thinking of or gain acceptance of others in sensitive situations 6) Able to work with limited supervision and be detail-oriented 7) Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents 8) Ability to respond to common inquires or complaints from customers, regulatory agencies or members of the business community 9) Ability to write speeches and articles for publication that conforms to prescribed style and format 10) Ability to effectively present information to top management, public groups, and/or boards of directors