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Job #02808

About our client Our client is a leading global producer of active pharmaceutical ingredients. The company has demonstrated strong growth and profitability in recent years and brings over a century of innovation to each of its 1500+ products. This is a great situation for a candidate that is pursuing a challenging and visible opportunity with a world-class employer. Position Location Director of Compliance New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Ensure that products are of the required quality for intended use, incorporating cGMP and other drug regulatory requirements 2) Manage all aspects of Quality Control, Quality Assurance, Regulatory Affairs, Quality Systems and Validation 3) Ensure that quality and regulatory procedures, policies and systems are developed and implemented 4) Interact with technical departments, customers, suppliers and regulatory agencies (i.e. FDA and DEA) in the review of issues and data 5) Ensure training of appropriate personnel in the application of procedures, policies and systems 6) Provide regulatory guidance and assessment of activities associated with the manufacturing of bulk pharmaceutical products 7) Ensure that all procedures, policies and systems stay current 8) Prepare and support submissions to FDA 9) Participate actively as a member of the senior management group 10) Manage implementation and adherence to all applicable SHE and cGMP regulations 11) Handle the performance management, training and coaching of personnel Requirements 1) Ph. D. in Organic Chemistry, Chemical Engineering or equivalent 2) Minimum 10 years of managerial experience in a cGMP, bulk pharmaceutical (API) environment, or M. Sc. in Chemistry with 15 years of experience 3) Previous experience in FDA as a National Expert or in a Senior Inspector role (a plus) 4) Working knowledge of DEA regulations and inspections an asset 5) Knowledge of environmental, safety and health regulations and inspections a plus 6) Hands-on experience in facility and laboratory inspections (customer and FDA), pre-approval inspections (FDA), process, product, equipment, automated system and computer (part validations and/or qualification inspections (FDA) 7) Experience in authoring or responding to 483 reports, warning letters, consent decrees and FDA 8) Excellent project-management skills 9) Ability to work efficiently with people across all levels and cultures 10) Excellent coaching and interpersonal skills 11) Ability to be a self starter, initiator and team player 12) Excellent verbal and written communication skills 13) Willingness to travel occasionally