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Global Director of Quality, Safety and Environmental

Company: Cypress Search LLC
Location: Bethlehem
Posted on: June 9, 2019

Job Description:

Growing company in the pharmaceutical capital equipment field can offer you an opportunity to build, develop and lead a global team in quality and safety . If you are a strategic professional seeking to apply your Leadership and Management skills than this opportunity will appeal to you.YOU WILL:Provide strategic Leadership of an international Quality Assurance and Quality Engineering teamEnsure cross-training of all Quality staff, so that all internal and external (service/installation) needs can be met.Review and evaluate site Quality staff performanceMaintain and ensure compliance to Standard Operating Procedures (SOPs).Support and maintain quality practices and guidelines, including best industry practices such a Good Documentation Practices (GDP).Participate in internal, process and mock customer audits, as directed.Perform vendor qualification or re-qualification audits, as directed.Coordinate 3rd party audits of specified site as directed (ASME, National Board, etc.)Coordinate and support Customer auditsSite liaison with Authorized Inspection (AI) Agency personnel (Vessel Manufacturing sites only).Coordinate team involvement in Pre-FAT, FAT, SAT, and IQ/OQ activities as required.Corrective Action & Preventive Action (CAPA)Coordinate assigned CAPA activities (Root cause analysis, short & long term corrective and preventive actions)Serve as a site CAPA mentor for assigned champions from other functions.Coordinate assigned Continuous Improvement initiatives, driving both cost and process improvements.Coordinate Quality System Change Management assignments as directedCoordinate calibration activitiesReport to the Global Director of Quality the status and metrics of the quality program for the specific site.First Pass Yields (from monitored Mfg. Processes), Turnover Package (TOP) Audits, ECN Review, MRB cycle times, Receiving InspectionTrend analysis of FAT/SAT punch list itemsQUALIFICATIONS:Bachelor's Degree, in an Engineering discipline or related Science field (ex. Chemistry, Metallurgy)5+ years post graduate work in a Quality or Validation fields2+ years of management or leadership experience.Experience developing, maintaining, and presenting quality standards and training.Strong proficiency in MS Office products.Knowledge of raw materials, production processes, quality control, and costcGMP, ISO 9000, or equivalentASQ CQE, ASQ CQM and Six SigmaKeywords: Factory Acceptance Testing, FAT, cGMP, ISO, ASQ, CQE, Six Sigma, CAPA, IQ/OQ

Keywords: Cypress Search LLC, Bethlehem , Global Director of Quality, Safety and Environmental, Executive , Bethlehem, Pennsylvania

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