SR. Manager Global ERP Validation

Job Category: IT/Software Development Company: Baxter Healthcare Reference Code: 32983BR SR. Manager Global ERP Validation 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. The experienced life sciences professional with a deep knowledge of GxP and ERP experience will find a challenging and rewarding career at Baxter Healthcare. We are seeking an experienced manager to lead the Global IT Validation efforts of the ERP Program. This manager will develop the quality and compliance strategy for Baxter's ERP initiative. This global leadership role requires an individual with sound judgment and the ability to apply a risk based approach to the validation process. The IT ERP Validation Manager will serve as a team member on the ERP project, maintaining independence from an organizational reporting relationship from the ERP program team. They will report into the IT Risk Management Organization. Working in conjunction with their Director and the Baxter Quality function, they will serve as the Subject Matter Expert for Baxter in the area of Validation for Computerized Software for ERP. The Baxter Global ERP program will be a multiple year project to design, develop and deploy a common ERP system to manage the key Finance, Supply Chain and Manufacturing process for all of Baxter's regions, functions and businesses.   Key Responsibilities: Develop and implement the Global IT Validation Strategy to be used on the ERP program. Translate the strategy into the validation plan. Define the resource requirements, budgets and project plan for the ERP program. Responsible for assuring the ERP system meets its requirements and is in compliance with Baxter policies. Ensure that documents in the Validation Package are appropriately approved. Provide oversight for creating, managing, and/or maintaining required documents and protocol execution. Provide overall direction and leadership for the Quality and Compliance ERP related staff with organization development plans and performance management assessments. Provide strong leadership in establishing, maintaining and meeting budgetary requirements for the ERP program. Develop and manage the relationships with key Baxter internal and external project leaders. Serve as the IT Champion for Quality within the ERP program, building awareness and understanding of quality and compliance requirements. Drive positive cultural change and clear employee accountability for quality and compliance QUALIFICATIONS: Candidate must have a Bachelor's degree. A Master's degree in computer sciences, engineering, or business is desirable. Quality Systems Certification desired, offered by any of the accredited American or International Associations. 8+ years of relevant experience including multiple Team Lead roles with Global ERP programs. This experience must include significant computer system validation knowledge. Strong knowledge and understanding of ERP Systems. JD Edwards preferred, but not required. Must have demonstrated past project implementation of validation activities on Global ERP programs, serving in the lead role. Valued member in a Fortune 500 and/or "Big 4 type" consulting/accounting firm desired. Past experience in Healthcare sector is expected. Track record of execution on large scale programs that meet quality, time and budget requirements. Proven ability to manage multiple priorities in a global matrix organization. Proven experience in managing staff who provide validation services to both infrastructure and system application projects. Must possess an understanding of software quality management principles and demonstrate a comprehensive knowledge of developing and implementing software quality programs. Proven experience in working to develop common approaches and frameworks, providing efficient and streamlined output, while still maintaining validation requirements. Must possess an understanding of the configuration management process to include planning, configuration identification, configuration control, change management, and status reporting. Must have had experience in implementing ERP systems with electronic records and/or electronic signatures, meeting 21 CFR Part 11 requirements. Proven track record of sound judgment including abstract thinking and a good balance between an academic and pragmatic approach. Excellent communication skills across IT and with business, functional and regional executives; being able to formulate vision and translate vision into execution with measurable results. Strong people skills, ability to mentor team members, build and lead teams with diverse backgrounds. Must be convincing champion for change to build quality and compliance culture within the ERP Program. Proven skills in managing project budgets, including the tracking, reporting and managing to keep actual budget on target to planned budget. 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.