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Quality Systems Manager

Country : USA USA

State : New York

Town : New York

Category : Production - Quality

Contract type : Permanent

Availability : Full time

Job description

The Manager, Quality Systems will develop new and evolve existing technologies to meet Quality business requirements. Specifically, this role will be responsible for managing and serving as the global data steward for Labware, our Laboratory Information Management System, and global quality analytical tools program manager. In doing so, this position will work closely with Site Quality, Manufacturing, IT, R&D, Engineering, Project Leads and other stakeholders to understand business requirements, analyze current systems & identify gaps, research new technologies and develop & execute implementation plans. As part of implementation, this role will ensure requirements are met, provide input into transition activities required and will support training development & delivery. Decision Making - Indicate type of decisions typically made and the overall impact of those decisions. Problem Solving - Indicate the nature of problems regularly encountered and the complexity of the solutions. Independence of Action and Accountability - Indicate the general degree of independence which may range from closely monitored to setting direction. Budget Responsibility - Indicate degree of financial accountability. Include actual amount of operating budget and/or cost savings. Include net sales plan responsibility, if applicable. Leadership - Indicate management responsibility including planning for the department's future needs, operations, hiring, performance management, salary decisions, talent planning, etc. (i.e., one team, multiple teams, etc.). Business Administrator and Global Data Steward for LabWare LIMS system. Responsibilities include: Manage the LIMS roadmap and implementing new capabilities Interface with global Directors and Managers (IT, QA, and Operations) to identify, communicate, and implement harmonized and optimized processes Develop and manage appropriate taxonomies to standardize quality and risk in LIMS Update and implement global standard operating procedures (SOPs) and work instructions (WKIs) Develop training programs and work with appropriate parties to train users Develop and improve tools to disseminate lessons learned Interface with other system owners to develop shared processes Identify metrics and tools to quantify and encourage LIMS success Serve as the corporate SME for said system. 60% Global Analytical Tools program manager. Responsibilities include: Act as an expert and thought leader on laboratory and/or manufacturing solutions and systems used to support quality-related processes, such working with R&D and Engineering on the development and implementation of new testing equipment or methods, and with Manufacturing on the implementation of new in-line control equipment and/or other shop floor digital tools, as part of driving Quality and excellence in manufacturing Work with Quality COE, Corporate Quality, site SMEs, process SMEs, R&D, Engineering and/or Manufacturing to identify needs for new in-line and off-line analytical quality tools Develop, prioritize, and maintain a roadmap of analytical tools based on strategic and tactical business priorities Keep abreast of trends in the industry Identify potential vendors to implement new tools, and lead work to select vendors in concert with cross functional partners including IT and IP Assist in developing costs and business case Work with appropriate parties including IT, IP, and Change Management to successfully acquire and implement new analytical tools Lead development of new SOPs and WKIs related to analytical tools Identify metrics and tools to quantify and encourage Analytical tools success Lead global team of SMEs 30% Training & Support. Responsibilities include: Support coordination, development and delivery of training on Quality systems, analytical tools and SOPs to manufacturing site Quality teams, Supplier QA, suppliers, TPMs, Manufacturing, and other relevant functions 10% Q

Profile

Embraces and Initiates Change: Distinguishes what to preserve and what to change. Has the courage to initiate and lead the changes that drive success. Builds Collaborative Relationships: Builds relationships based on trust and respect. Promotes the inclusion of diverse knowledge, skills, and experiences to achieve results. Drives Creativity and Innovation: Focuses on areas of highest potential. Creates newness or connects knowledge in new ways to create the unexpected. Ensures that the creativity and innovation pipeline are aligned to achieve strategy and goals. Strives for Excellence in Execution: Proactively seeks ways to improve personal and organizational effectiveness to meet current and future business needs. Learns equally from successes and failures. Expected to be skilled in LIMS. Experience with LES/ELN/Empower is a plus. Expected to have experience in Quality Assurance role Laboratory bench testing experience is a plus Experience with analytical in-line and off-line testing equipment is a plus
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