Project Mgr I Info Sys Quality
Westlake Village, CA
Req ID 46390BR
Business Title
Project Mgr I, Info Sys Quality
Business
Global Quality
Sub-Business
BioScience Support
Country
US
State/Province
California
Location of Position
Westlake Village, CA
Shift_
1st
Job Description
Responsible for managing or overseeing compliance projects for information (computerized) systems (IS) used within the BioScience Division in partnership with Global Information Technology (GIT) or other functional groups as applicable to the business process. Responsible for results in terms of milestone achievement, conformance to interan/external (FDA) regulations and Baxter quality policies.
Accountable for contributions to the quality of project delivery by performing project-applicable Quality Compliance functions, and ensuring that the system developed meets the requirements defined. Responsible for monitoring compliance to the CQPs/local procedures, FDA regulations - including but not limited to Code of Federal Regulations (CFR) Title 21, Part 11 Electronic Records & Electronic Signatures - and Baxter QMS.
Essential Duties and Responsibilities:
•Presiding as Subject Expert Matter (SME) for Quality Processes in the area of IS Quality and Validation.
•Assuring a system/application meets its requirements and is compliant with applicable Baxter QMS documents, FDA regulations, and the documentation set outlined in the Validation Plan for the project.
•Approving documents required for the development and validation of the computerized system.
•Forming a partnership with the business process owner and acting as the liaison with Global IT.
•Ensuring Quality milestones are successfully accomplished and project status is adequately communicated.
•Creating or improving division procedures by leading cross-functional working teams to develop and deploy quality IS processes that are standardized across the BioScience division and leverage best practices for business efficiency
•Preparing and providing training and/or supporting the facilities' training for the Corporate, Global IT, Division and local procedures.
•Assisting in CAPA resolution if issues around computerized systems arise.
•Participating in quality assessments of internal operations and suppliers to assess compliance and risk.
•Interfacing with inspectors/auditors when computerized systems or their documentation is being inspected or audited.
•Maintaining expertise in areas of responsibility through ongoing training and participation in industry associations.
•May be responsible to present application-specific Computerized Systems Validation packages to auditors.
Job Requirements
•Experience with Quality Systems realted to IT systems, preferably in a FDA regulated manufacturing setting.
•Working knowledge of applicable procedures, specifications, regulations and standards, including, but not limited to: ISO 9001-2000, ISO 13485, FDA CFR 606, 211, 820, 11, and European GMPs.
•Thorough knowledge of applicable procedures, specifications, regulations and standards for computerized systems quality and validation.
•Strong analytical and problem solving skills.
•Ability to manage projects in a dynamic environment.
•Ability to partner with both the business process owners and IT management and staff.
•Good communication, presentation and leadership skills.
•Self motivated with good interpersonal, communication, influencing and negotiation skills.
•Good project management skills, with the ability to manage multiple projects at once.
•Good computer skills, excellent writing, organization and presentation skills.
•Must be able to travel, if needed. Education and/or Experience:
BS in science or engineering. 8+ years experience in a Quality Systems Environemnet, Manufacturing, Engineering or related field.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
