Nature and Scope Leading and managing a multi-disciplinary team, consisting of process investigation leads as well as manufacturing process engineers, the Operational Excellence Manager must possess the ability to manage multiple tasks simultaneously, including the management of critical projects, critical timelines, sophisticated investigations, and annual product reviews in an FDA regulated environment. The Operational Excellence Manager will be responsible for driving the Operational Excellence team to meet overall customer service metrics by identifying and implementing process improvements, closing CAPAs and reducing overall investigations that impact batch release thus impacting customer service metrics. This Operational Excellence Manager and team will support both our commercial including aseptic manufacturing and as required, our Research & Development and Validation operations. The Operational Excellence Manager would be required to chair meetings, present topics to the leadership team, develop and provide metrics and provide consistent professional communication throughout all levels of the organization. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Develop working instructions, workmanship standards and process documents, and ensure they are followed. Responsible for developing Operational Excellence Tools and leading process improvement, Culture Change, and cost reduction activities. Champions a continuous improvement culture and provides expertise and leadership on Lean Principles and Problem Solving. Supports the site to meet operational and financial targets and identifying Best Practice opportunities utilizing a data driven approach. Work with Operational Excellence Director in establishing and building the site's operational excellence program, integrating Lean and Six Sigma programs. Vital focus will be on ensuring projects and approach is fully integrated in organization. Ensure that operational excellence methodology is utilized to drive sustainable manufacturing and business process improvements that optimize capacity, reduce lead-time, minimize inventories, maximize fill-rates, process flow, and productivity. Identify where continuous improvement systems are required to optimize manufacturing and transactional process, design and implement the solution ensuring system is designed for scalability and for sustainability. Responsible for ensuring solutions and changes are fully integrated into organization and become "the way we do things around here." Actively encourage, promote, and facilitate implementation of creative solutions to ensure quality while delivering lower costs and shorter lead times. Ensure all transformation changes are conducted to the highest of standards in a safe, compliant and effective manner. Work with the manufacturing organization to streamline processes and drive transformation through the driving the timely closure of investigations and CAPAs to change the culture of with focus on customer demand along with continuous improvement. Lead process of selecting projects that align with financial goals, KPIs and strategies, and track running projects in co-operation with Site Management. Takes lead on identified projects and has the ability to communicate clearly through facts and data the benefits and expected results to Site Management, ensuring the best possible support on completing projects. Facilitate Kaizen events and other improvement projects. Owns the continuous improvement process, escalation & cascade of KPI's and the improvement dynamics of them. Oversee that processes are in CGMP compliance and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop know