1 Works with a cross functional team to ensure that compliance gaps are appropriately addressed.
2 Ensure projects/improvements are implemented within stated goals and timelines.
3 Leads teams in defining program strategies, developing goals, assigning project tasks, and ensures the team meets all goals. Gives input into all team members performance evaluations.
4 Using project management tools develops mechanisms for monitoring project progress and for intervention and problem solving with project managers, line managers and other manufacturing managers.
5 Using investigation/lean tools develops robust root cause analysis and drives robust actions to ensure elimination of root cause.
6 Interacts through program updates and reviews with all levels of management.
7 Participates with other managers in setting the project strategy, schedules, resource alignment, and financial analysis.
8 Approves team deliverables for project completion.
9 Provides technical support in all phases of investigation. Teaches others to use investigation/lean tools to resolve nonconforming situations.
10 Anticipates and resolves conflict situations in a win-win outcome.
11 Utilize engineering tools to solve straightforward problems (e.g., FMEA, Finite Element Analysis, Process Modeling, Design of Experiments, Mold Flow, SPC, software development).
12 Study and recommend techniques to improve existing products/processes.
13 Select sound techniques to solve problems and make design recommendations under direction of supervisor. Assess results for application, validity and conformance to specifications.
14 Assists in the training of more junior team members.
Ability to drive change and motivate others toward a common vision
Ability to lead teams that are not direct reports
Demonstrated facilitation, problem solving, and analytical skills
Demonstrated sound judgment. Must be confident, resourceful, self-reliant and self-motivated.
Understanding of cGMP regulations (US, EU, Japan, Canada, etc.), and quality management systems for pharmaceutical, device, biologics or biotechnology operations as applicable to the facility.
Experience in manufacturing and/or quality operations.
Strong knowledge of Quality Systems.
Strong interpersonal/influencing/negotiating skills.
Strong communication and presentation skills, both oral and written with a demonstrated ability to present key quality/department/business indicators to senior management.
Strong project management, organizational, planning and analytical skills.
Must have a working knowledge of project management and investigation/lean tools and possess knowledge of related disciplines.
Excellent Microsoft Office Suite knowledge (e.g., Excel, PowerPoint, Project, etc.)
Bachelor's degree in Engineering or Science. In addition, a minimum of 3-5 years in manufacturing or quality operations in a pharmaceutical, device, or biotechnology environment.
PMP (Project Management Professional), Lean/Six Sigma, and/or Lead Investigator Training Certification is preferred. Prefer experience with TQM methods.Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers . EOE M/F/D/V.
CareerBuilder - 20 months ago
axter International Inc. (NYSE: BAX), is an American health care company with headquarters in Deerfield, Illinois. The company primarily...