Quality Site Head

This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13677737 Who we are Fagron was founded in Rotterdam (The Netherlands) in 1990 and is a dynamic organization with over 3,000 employees worldwide. As the global market leader in personalized medicine, we are highly passionate about being at the forefront of our field. Each day, we are committed to improving the lives of millions of people across the world by optimizing and innovating personalized pharmaceutical solutions. If you would like to be part of such an important challenge and feel you would thrive among dedicated and passionate colleagues, then chances are you will discover a career at Fagron that you'll love! Together we create the future of personalizing medicine. About the job Quality Site Head for the 503B Outsourcing facility in Wichita, KS of approximately 600 personnel. Responsible for the overall maintenance and continuous improvement of Quality Systems so that they are compliant for Federal (FDA) and State (Board of Pharmacy) regulatory organizations. Oversees Quality Assurance activities, including incoming and final product release, complaint management, data management, calibration and validation requirements, conducting investigations and managing change controls and other activities as required to contribute to the assurance that final product is fit for use. Oversee Quality Control requirements, including analytical contract laboratory, microbiological and environmental testing as well as general lab maintenance activities. Oversee Training to ensure that all facility staff are trained in department specific activities, Quality Systems, SOPs and Good Manufacturing Practice, as relevant to their role. Responsible for leading company management reviews as well as inspections and other Regulatory and compliance activities. Key Responsibilities - Oversee all Quality matters at the facility, such as disposition of incoming materials and final product, review and acceptance of Quality control analytical and microbiological testing, completion of Environmental monitoring activities, management of Quality systems for deviations, change controls and CAPAs, validation and maintenance of equipment, quality support of clean room activities, training development and maintenance, and general Quality compliance activities. - Participate in budget planning, including project, personnel and equipment estimations. - Manage and develop direct reports through workload planning and prioritization, leadership, guidance and open communication. - Ensure compliance with all relevant cGMP and corporate Quality System requirements. - Has authority to make decisions for the QA and QC departments in internal and external meetings. Plans for resources and administrates Quality budget, with regards to personnel, equipment, and facilities. - Ensure all Deviations, Excursions and OOS situations at the facility are properly investigated, have appropriate corrective actions and are closed in a timely manner. - Leadership of Regulatory/FDA inspections and customer audits by providing information or expediting/obtaining information required by the inspectors/auditors, and follow-ups where corrective action is required. - Participate in the scheduling, performance and response to internal and external inspections and audits. - Directs investigations of product complaints and manufacturing discrepancies for manufactured products and ensures completion of appropriate documentation. - Interacts with Pharmacists and Regulatory as needed. - Supports human resources to better accomplish and develop personnel as professional quality managers, supervisors, and technicians. - Ensures coordination of the monthly/quarterly metrics / KPIs for the site, as well as preparation, review, and approval of the semi-annual FDA product reporting and Annual Product Quality Reports. - Participate in meetings with customer management, prepare and present reports on quality metrics and compounding center performance. - Explore, evaluate and implement new technologies and/or procedures that optimize the technical performance and efficiency of the facility. - Ensure all documentation is in compliance with company and regulatory requirements. - Complete all required reports and administrative tasks within designated timeframes, including, expenses, etc. - Maintain current knowledge of topics relevant to role and to the business, and US and International standards through attendance at seminars, lectures, meetings and professional conferences Set yourself apart Maintain knowledge of technological advancements in areas relevant to role, including, clean room technology and specialized instrumentation. Maintain up-to-date knowledge of industry trends, cutting-edge practices and techniques, current publications, and regulations relevant to role and business. Maintain up-to-date knowledge of SOPs and policies and ensure compliance at all times. Understand internal and external customer issues and requirements. Ensure all Company r