Life Science Quality Assurance Manager

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Life Science Quality Assurance Manager JOB TITLE: Life Science Quality Assurance Manager SUMMARY: The Quality Assurance Manager is responsible for managing and directing the activities of the account Quality Assurance team. He/she works with the Life Science Global Regulatory Center of Excellence (LS GR COE) and account managers and executives to assure GTS services are delivered in a compliant, efficient, and consistent manner to meet client needs. The Quality Assurance Manager implements the Life Science Industry Quality Management System on the account and directs quality assurance reviews of project deliverables and operations from transition through steady state operations. ESSENTIAL DUTIES AND RESPONSIBILITIES: Coordinate with the LS GR COE on all compliance policy issues, quality management system (QMS) documents, compliance metrics, and training activitiesServe as the principal liaison with the client quality assurance organization on quality assurance and regulatory compliance issuesManage the activities of the account Quality Assurance Team to assure that the account delivers infrastructure services in accordance with life science industry regulations and client expectationsProvide oversight and direction to account infrastructure qualification and computerized system validation projects to assure testing projects comply with Life Science QMS procedures and regulatory requirementsManage quality assurance reviews qualification and validation projects and advise operational counterparts on the proposed approach, disparities from regulatory requirements or corporate standards, and consistency with contemporary testing techniquesProvide oversight and direction to assure the account is prepared to host regulatory and client compliance audits and resolve audit findings completely and in a timely mannerProvide compliance direction to the account transition teams in developing project plans that will assure projects are delivered in a compliant and efficient mannerMaintain a close working relationship with account project and delivery executives to assure that compliance operations are aligned with business objectives and client expectationsCollect and report compliance metrics to the LS GR COE and account managementParticipate in the development and planning of corrective and preventative actionsEnsure optimum performance of team function. Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practicesMaintain an up-to-date knowledge of life science industry regulations, quality assurance practices, infrastructure qualification and computerized system validation practices and proceduresPerform all other related duties as assigned QUALIFICATIONS:Education:Bachelor's degree (B.A./B.Sc.) or equivalent from four-year College or University in a scientific discipline or related fieldTraining in GxP (Good Clinical Practice, Good Laboratory Practice, or Good Manufacturing Practice) regulations and quality assurance principlesTraining in infrastructure qualification in the life science industryTraining in computerized system validation in the life science industryTraining in electronic record keeping and electronic signature (ERES) regulations and associated regulatory agency guidanceto