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Baxter Healthcare Corporation Mgr II, Quality JR - 146146 in Byhalia, Mississippi

This is a job for a Mgr II, Quality with a company located in the Byhalia, MS area.

Job Summary: Join our Engineering department as the Mgr II, Quality and have an outstanding impact on our global logistics operations. As a leader, you will be responsible for achieving metrics, facility goals, and implementing Behavior Based Quality initiatives. Your focus will be on ensuring compliance and product quality, supplying to the flawless operation of our systems.

Responsibilities: Manage through direct subordinates the coordination of all aspects of the Mt. Carmel Global Logistics Center (GLC) Quality Management System, including direct support of Mt. Carmel GLC Operations. Ensure compliance with all state and federal regulations through the deployment of Baxter quality policies. Operate autonomously, routinely managing issues without the benefit of onsite supervision. Showcase efficiency in task completion, decision-making, empowerment of others, exception management, training, problem-solving, and team building and leadership. Apply functional knowledge of FDA requirements and ISO standards. Serve as the Mt. Carmel GLC Quality Management Representative (QMR) and be responsible for deploying the Baxter Quality Policy. Handle activities of the Quality organization, providing oversight and daily management of all elements of the warehousing and distribution operation (e.g., Inventory Control, Cold Chain, DSCSA) and QMS (e.g., Management Review, Audits, CAPA, Change Control, Supplier Quality). Maintain compliance with state and federal regulations for the sale and distribution of pharmaceutical drugs and devices. This includes registering at the state level and taking responsibility for the actions of the site. Collaborate with Operations, Fulfillment, and Quality leadership to lead day-to-day operations, new business partner integration projects, process improvements, and the implementation of new technology. Act as the primary interface for all regulatory inspection and customer audit activity related to products and processes. Identify and lead continuous improvement projects with the objective of achieving quality, reliability, and cost improvements. Provide mentorship, training, and coaching to subordinates to ensure ongoing development. Learn, understand, and apply rigorous quality standards, i.e., Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP). Implement quality systems procedures in several sections or departments and handle compliance. Participate in or lead quality assessments of internal operations and suppliers to analyze compliance and assess risk. Interact frequently with internal subordinate supervisors, functional peers, and senior group managers. Work overtime, as needed.

Qualifications: BS in science or engineering; advanced degree preferred. Seven (7) years of experience in Quality, Manufacturing, Engineering, or Warehousing & Distribution in a regulated industry required, with management/supervisory experience. Detailed understanding of relevant procedures, specifications, regulations, and standards. Ability to lead/supervise a large team of employees.

Equal Opportunity Employer -- minorities/females/veteran/other individuals with disabilities/sexual orientation/gender identity.

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