Supplier Quality Manager

Job Category: Accounting/Finance/Insurance Company: Baxter Healthcare Reference Code: 33059BR Supplier Quality Manager 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 overall facility Supplier Quality program. Responsible for sub-systems such as material specifications, experimental specifications, supplier notification of change, supplier quality agreements, supplier investigations, approved supplier list and supplier quality metrics. Responsible for administration of Trackwise Supplier Quality Database. Responsible to apply QLP tools to supplier quality to improve performance and compliance and Receiving/Inspection process. Lead and/or assist with investigations related to raw materials/component issues. Serves as interface to Regulatory Affairs for assessment and approval of significant supplier notification of changes. Single point of contact and Division interface for Supplier Quality. Responsible for implementing Corporate and Division Supplier Quality initiatives. Supports the Thousand Oaks facility during external and regulatory inspections as the point of contact for Supplier Quality. Works closely with senior facility management in managing the inspection process. Works closely with other QA departments and manufacturing operations in the areas of cGMP compliance and quality systems. Responsible for managing a staff of quality assurance personnel for day-to-day quality operations. Responsible for employee training, development and performance evaluations for direct reports. Responsible for setting annual budget; responsible for managing resources in order to meet annual budget. QUALIFICATIONS: Bachelor’s degree in Sciences or Engineering. Minimum 5 years experience in a quality operations function in a biotechnology, biologics, or pharmaceutical manufacturing facility. Minimum 1 to 2 years previous leadership, supervisory or management experience required. Demonstrates strong proficiency in supplier quality and other related quality systems (exception management, change control, document control, etc.) with strong decision making skills utilizing risk management Able to lead multiple tasks/projects within timelines Strong verbal, written and oral communication skills. Able to present business indicators to senior management Strong knowledge of cGMP (US, EU, Canadian, Japan) required  Strong knowledge of USP and EP required Knowledge of manufacturing and laboratory operations preferred  Able to present areas of responsibility to regulatory agencies during inspections Proficient in problem solving through the use of continuous improvement tools. Able to use continuous improvement tools; certification desired in ASQ, Green Belt, Lean, or equivalent. Able to manage employees, conduct performance reviews, establish development plans and manage resources 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.