Director, Quality Control Lab

Director, Quality Control LabThe detailed duties and responsibilities of the Director, Quality Control Lab will include:Provides leadership, guidance and direction to QC lab to support the departments and company s strategic initiatives and goalsWork with our industry partners and scientific affiliates and contribute to the advancement of analytical technologies and method researchImplement innovation ideas and continuous improvement activitiesDevelop metrics and reports to assess performance, trend and analyze data and take appropriate actions as appropriate. Track, report and provide periodic reports to management in support of Quality Metrics. Leverage data to improve product quality and laboratory efficiencyManage laboratory operations and maintain the laboratories in compliance with ISO17025 accreditation requirements and other applicable local laws/regulationsInitiate investigations for non-conforming product and develop Corrective and Preventive programLiaise with the regulatory authorities on laboratory operationsResponsible for applying inspection standards to products shipped directly from contract manufacturers to outside locationsDevelop and maintain a system that assures all certificates of analyses are reviewed against required finished product specifications as written in Agile PLM (Product Lifecycle Management)Periodically perform a mock recall to assure that the systems have qualified and acceptable traceability standardsDevelop training program to chemists and technicians for compliance with Good Laboratory Practices and current Good Manufacturing PracticesManages chemists, technicians, and laboratory supervisorsTechnical Qualifications:Strong leadership skills with expertise in implementing quality processes, systems and strategiesStrong knowledge in laboratories operationsStrong knowledge in ISO17025 requirementsStrong proven hands-on experience with variety of both GMP and GLP mattersStrong verbal and written communication skills with ability to work with a high degree of accuracy and detailStrong interpersonal skills and the ability to work well as part of a teamExperience:10+ years of laboratory operations experienceEducation:Bachelor s degree in life science or equivalent technical field**If you d like to hear more about this opportunity and others we are currently working on, please contact Sam Kovacevic at skova cps4jobs.com.JO: 44.24KK#LI-SK3