Project Mgr I Quality

Project Mgr I Quality

Westlake Village, CA

Req ID 50062BR

Business Title
Project Mgr I, Quality

Business
Global Quality

Sub-Business
BioScience Support

Country
US

State/Province
California

Location of Position
Westlake Village, CA

Shift_
1st

Job Description
Summary: Responsible for the management (development, deployment, maintenance and improvement) of Quality processes and procedures related to CQM07 Monitoring and Improvement processes. 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 and is unlikely to have direct reports.
Essential Duties and Responsibilities:

•Presides as Subject Expert Matter (SME) for Quality Systems and Processes in the area of monitoring and continuous improvement. •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/supported. •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. •May participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk. •Supports continuous improvement activities to achieve quality, reliability and cost improvements (Kaizens, Lean/Six Sigma projects) in division Quality including Division Quality Strategic Planning, BOS Assessment •Supports Division Quality functions in identifying Lean/Six Sigma projects and GB candidates •Coaches team members on basic and advanced Lean/Six Sigma tools including VSM, Standard Work, FMEA, sampling, and SPC; acts as SME for Root Cause Analysis, statistical analysis •Facilitates and/or supports division quality operating mechanisms such as Management Reviews, Strategic Planning, Quality Dashboard, other workshops •Manages high-priority, cross-functional projects sponsored by division quality •Supports and/or facilitates PMM project phase gate reviews

Job Requirements

•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. •Excellent leadership, interpersonal, communication, influencing and negotiation skills. •Good organization, prioritization and follow up skills; have the ability to overcome obstacles and deliver results with minimum supervision •Demonstrated history of top performance •Strong project management skills based on sound engineering, and scientific principles with cGMP foundation •Good oral and written communication and presentation skills. Must be able to communicate well with all levels of professionals (national and international) •Minimum 7-8 years of professional experience and 3-4 years of project management experience •May have up to 20% travel •Strong analytical and problem solving skills including statistical analysis •Advanced user of MS Excel, MS PowerPoint, and Minitab •High degree of customer sensitivity/acumen; establishes and maintains credibility with internal/external customers

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.