Provide strategic and operational leadership for a multi‐product, fda‐regulated manufacturing organization. This role shapes production strategy ensures compliant and efficient operations across multiple shifts and builds scalable manufacturing capabilities aligned to business objectives. Partnering cross‐functionally with r&d, quality, regulatory, supply chain, and engineering, the role enables successful product transitions, drives continuous improvement, mitigates operational risk, and develops high‐performing teams to deliver quality, cost, and supply excellence.highly experienced in production managementin addition to the day‐to‐day managerial function, the role incorporates the strategic and policy development aspects that have medium term consequences on the operation of the function and perhaps impact elements of organization performancekey member in the formulation of production strategy, policy and proceduresdevelops and oversees production activities to maximize the use of the organization ́s resources and meet established production specifications and schedulesoversees manufacturing activities of multiple product lines operating on multiple shiftsdevelops and implements short and long term strategic plans to ensure manufacturing systems are in place to meet business objectivesworks cross‐functionally with r&d, quality, clinical, regulatory and other departments as needed to ensue effective product transitions into productionworks with supply chain management to develop effective, production planning and inventory systems; works with continuous improvement and engineering functions to develop effective manufacturing processes capable of meeting quality, cost and supply chain objectiveshires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Supports all company initiatives as identified by management and in support of quality management system (qms), environmental management systems (ems), and other regulatory requirementsfood and drug administration (fda) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers contractors, and vendorsmaster's degree in industrial engineering, business administration, or engineering fieldsmanufacturing and operationsvalidations and ramp up productionexperience in training large organizations and achieve ramp upsknowledge of financial statements, experience in planning, budgeting, forecastingquality processesunderstanding of quality processesmanage manufacturing expectations including capas and non‐conformancesbusiness acumenexperience working in a broader enterprise/cross division business unit model preferredability to work in a highly matrixed and geographically diverse business environmentstrong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business resultsstrong organizational, planning, and follow‐up skills and ability to hold others accountablefully bilingual (english & spanish)#