Project Manager, Quality

Job Category: Quality Assurance/Safety Company: Baxter Healthcare Reference Code: 31867BR Project Manager, Quality Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives. Responsible for the management (development, deployment, maintenance and improvement) of Quality processes and procedures in the area of Microbiology and Environmental Monitoring. Represents BioScience in Baxter division and/or corporate improvement teams to ensure effective deployment of requirements both internal and external into the division procedures. This is a project management role Presides as Subject Expert Matter (SME) for Quality Processes in the area of Microbiology and Environmental Monitoring Responsible for creating or improving division procedures by leading cross-functional working teams to develop and deploy quality processes that are standardized across the BioScience division and leverage best practices for business efficiency Responsible for preparing and providing training and/or supporting the facilities' training for the division procedures developed Maintains expertise in the area(s) of responsibility through ongoing training and participation in industry associations Supports division wide activities that relate to key responsibilities. Represent BioScience on Baxter councils, committees, task groups, etc. in areas of expertise Understands and assures conformance to requirements and regulations. May interface with regulators during regulatory inspections Participates in or manages quality assessments of internal operations and suppliers to analyze compliance and assess risk Participates in budget development and ensures adherence to the budget. QUALIFICATIONS: Experience with Quality Systems preferably in a FDA regulated manufacturing setting Thorough knowledge of applicable procedures, specifications, regulations and standards, including ISO 9001-2000, ISO 13485, FDA CFR 606, 211 & 820, and European GMPs Strong analytical and problem solving skills Ability to lead a team of multi-facility and function employees to a successful project outcome Good communication and leadership skills Good interpersonal, communication, influencing and negotiation skills Good project management skills Good computer skills, proficient writing, organization and presentation skills Must be able to travel extensively, if needed BS in Microbiology or equivalent. 5+ years experience in Quality, Manufacturing, Engineering or related field which should include 1-2 years of supervisory experience As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits. To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V.