Sharon Donnally

***** ************ ***** 317-***-**** (W)

Fishers, IN 46038

317-***-**** (C)

Key Skills and Knowledge Areas

• Project Management • Process Improvement •Negotiation

• Six Sigma Green Belt • Problem Solving •Global Relationship Building

• People Management and Development •Decision Making •Results Driven

Experience

Roche Diagnostics (Indianapolis, IN)10/06-Present

Global Labeling Manager, Roche Professional Diagnostics

Provide leadership for, manage and develop the Global Labeling staff consisting of Communications Consultants, Labeling Specialists, and Packaging Engineers. Serves as the primary US focal point and global representative for the development and implementation of product labeling software and strategies for the RPD division.

Key Accomplishments:

Served as Project Leader for the Warehouse Transformation Master Data Project.

Served as Ready Room Lead during FDA inspections conducted in 2005 and 2007.

Served as interim Project Leader for the RPD Manufacturing Validation Project.

Served as Project Leader the 30 KD filtered Urine project, which is part of the CD manufacturing transfer project.

Lead the team which developed a plan for transferring all RPD OEM products to Germany.

Developed, obtained global agreement on, and implemented multiple packaging and labeling process improvements such as: Calchecks value sheets, Application Sheet development, in-line printing process, and a process with Germany to develop FDA acceptable labeling.

3/02-10/06 Global Labeling Supervisor, Centralized Diagnostics

Directed U.S. labeling activities to ensure adherence with global and U.S. regulations. Served as Global Labeling representative responsible for negotiating/coordinating labeling activities with Germany and other business units.

Managed labeling personnel to effectively support new product launches and maintain existing product portfolio.

Selected, trained, coached and developed Global Labeling team.

5/99-3/02 Global Labeling Communications Consultant, Centralized Diagnostics

Developed, maintained, and conducted content approval for CD product labeling.

Interacted daily with local and global departments within Roche to insure that labeling distributed in the US conforms to all US and Global Regulatory requirements.

Boehringer Mannheim (Indianapolis, IN)

3/97-5/99 Project Management Consultant Supervisor, Laboratory Diagnostics

Project Leader for coordinating the availability of ~ 150 reagents needed for the launch of the MODULAR analyzer.

Member of Global MODULAR Reagent Team, which involved extensive communication with RDG colleagues to insure that US/RDG reagent schedules are harmonized.

Project Leader for various US reagent project launches, which included creating and maintaining project schedules, leading team meetings, and writing minutes.

Supervised Project Management Consultants in the group and developed/implemented process improvements for managing LD Projects.

5/94-3/97 Project Management Consultant, Laboratory Diagnostics

Created and maintained project schedules based on input from team members.

Identified and addressed process and resource conflicts across projects.

Project Leader for ISE reagents and Liquid Bilirubin projects.

3/92-5/94 Supervisor, Technical Support, Laboratory Diagnostics

Supervised 13 Technical Support Specialists.

Responsible for resolving high level customer concerns, developing staff training plans, and insuring staff coverage for 24 hour operation.

5/88-3/92 Technical Support Specialist II, Laboratory Diagnostics

Assisted customers in phone troubleshooting of BMC/Hitachi chemistry analyzers.

Received Peer Recognition Award in 1990 for outstanding team work and peer support.

3/87-5/88 Scientist, Laboratory Diagnostics Quality Assurance Laboratory

Conducted quality control procedures on all clinical chemistry reagents manufactured by Boehringer Mannheim, Indianapolis.

Riley Children’s Hospital (Indianapolis, IN)

8/86-3/87 MT(ASCP) Certified Medical Technologist in Chemistry Laboratory.

Education

Butler University (Indianapolis, IN)

• Master of Business Administration degree received in May, 1993.

• Cumulative GPA= 3.7 out of 4.0.

Medical Technology Program, Indiana University School of Medicine (Indianapolis, IN)

• Bachelor degree in Medical Technology, July, 1986.

• Cumulative GPA= 3.7 out of 4.0. Graduated with High Distinction.

• MT(ASCP) Certification obtained in September, 1986.

Jay County High School (Portland, IN)

• Cumulative GPA= 4.0 out of 4.0.

Other Certifications and Training Courses Completed

• Project Management Professional (PMP) Certification obtained on 8/4/2010.

• Six Sigma Green Belt Certification obtained on 2/13/2006.

• AMA Project Management Course, Kerzner’s Project Management Certificate Program: 9/26/1996.

• Completed Roche Leadership Development Training in 2008.

• Completed other various Management, Leadership and Facilitator courses offered through Roche.

• CfPIE: Labeling and Labeling Controls in the Medical Device Industry Course, September, 2009

• Dale Carnegie Course in Public Speaking and Human Relation: November, 2000

• Software package proficiencies include: MS Word, Excel, Powerpoint, Visio, and Project.

• Currently pursuing a Master of Information Systems Management Degree from Keller Graduate School of Management. Classes Completed: Essentials of Information Systems and Programming, Networking Concepts and Applications, Project Management Systems.

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