Manager, Global Clinical Supply Chain Compliance Operations

Job Description

Position Summary The Global Clinical Supply Chain Compliance Manager ensures GxP compliance in GCSC by providing QMS operational support and partnering in business activities, while identifying and supporting process improvements. The role involves managing Global Clinical Supply Chain compliance, monitoring process performance, performing trend analysis and supporting audit/inspection readiness. The incumbent will proactively identify/report to management operational and systemic compliance issues and/or risks related to clinical supply chain end-to-end processes Responsibilities Collaborate with GCSC functions to maintain GxP compliance and to support business activities in compliance with procedural requirements. Serve as advisor and functional expert as an accepted body of knowledge and experience in area of expertise. Collaborate with GSC Global process owners in designing, managing, and improving capabilities. Monitor compliance, report performance metrics and perform trend analysis for processes as required. Monitor status of CAPAs to ensure GCSC commitments are met; follow-up as required with e-QMS record owners for the timely completion/extension before their due date Participates in Clinical Supply Chain Quality Council meeting as Data Steward/Metrics SME Own / support eQMS records such as deviations, change controls, CAPAs, pro-active initiatives, stand-alone actions, and risk assessments on behalf of GCSC functions. Perform role of lead investigator for assigned deviation and/or investigational medicinal product quality complaint records as required. Lead GCSC personnel in preparing for audits and inspections by identifying potential areas of risk and developing risk mitigation strategies and acting as primary CSC point of contact Conducts root cause analysis to develop responses to audit and inspection findings Collaborate with functional areas to determine best solutions to resolve any identified compliance issues Identifies and escalates technical and/or business issues promptly; must be able to have the ability to solve routine issues independently. Contributes to the development of procedural documents as needed. Support cross-functional/strategic initiatives and continuous improvement projects as assigned Exercise sound judgment, using a risk-based approach, to ensure compliance with PD regulations, practices, and policies. Contributes to or manage strategic initiatives and continuous improvement projects as assigned. Collects and shares best practices through direct communications and communities of practice. Maintain a contemporary knowledge of current industry trends, standards, and methodologies as it relates to quality systems and management. Designee Role and Responsibilities GCSC Compliance Manager may be delegated responsibility for eQMS activities such as Infinity change owner, deviation owner etc to support GCSC roles for example - Trial Supply Manager Required Competencies Excellent interpersonal skills Excellent communication skills Technical writing capability Good time management and organizational skills Ability to multi-task numerous projects Ability to work with initiative Ability to achieve targets and milestones Flexible and motivated Data analysis Supply Chain Acumen Confident public speaker Ability to solve routine problems Required Qualifications and desired experience Bachelor s degree in Supply Chain, Engineering, or related Scientific/ Technical discipline Experience / Knowledge Desired More than 5 years in a compliance and/or quality assurance. Working knowledge GCP/GDP/ GMP and of e-Quality Management systems (eQMS) e.g. Veeva Vault Minimum 3 years experience in Clinical Supply Chain Management or related field (ex. Interactive Response Technology (IRT), Drug Development, Clinical Operations, etc.) General knowledge of all phases, processes, and functions of drug development. General knowledge of investigational material supply chain processes. Experience working in a highly regulated environment Cross functional collaboration experience developing systems and standard ways of working, digitized metrics and reporting