Heather Thompson
Senior Labeling Project Manager
Lafayette,IN
Summary
Dynamic and results-driven Medical Device Labeling Project Manager with over a decade of leadership experience, adept at steering multiple complex projects to successful completion. Exceptional self-motivation and a proactive approach consistently deliver outstanding outcomes across diverse tasks. Expertise in organization, strategic planning, rapid learning, and innovative problem-solving is complemented by a talent for training and mentoring team members to achieve excellence. Known for effective communication and a positive, collaborative attitude, consistently surpasses company expectations by skillfully navigating challenges and fostering a high-performance team environment.
Overview
10
10
years of professional experience
Work History
Senior Labeling Project Manager
Acolad
02.2025 - Current
- Successfully managed multiple labeling projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
- Developed comprehensive project plans with clear scope, timelines, and milestones, ensuring timely delivery of high-quality results
- Contributed to successful product launches by coordinating with various departments to ensure all necessary inputs were obtained.
- Led team members in project management best practices to enhance their skills and contribute to better overall performance.
- Coordinated with cross-functional teams to resolve project issues and mitigate risks.
- Collaborated with cross-functional teams to identify areas for improvement and develop actionable solutions.
- Designed a robust solution for documenting and monitoring labeling update requests
- Oversaw hiring efforts to align talent with organizational goals
Labeling Project Manager
Globus Medical
10.2022 - 02.2025
- Created and continuously improved formal labeling program
- Led the labeling team by developing project scope, managing timeline, and monitoring employee performance
- Developed and executed global labeling strategies to maintain synergy among differing global regulations
- Transitioned all EU labeling content to be MDR compliant
- Investigated and documented labeling CAPAs
- Successfully consolidated multiple labeling programs into a single source
- Resolved production printing issues and addressed project delays
- Initiated and updated quality system instructions, SOPs, and BOMs for product development and continuous improvement efforts
- Assisted in providing technical document submissions and responses to notified body audits
Senior Product Labeling Specialist
Cook Biotech Incorporated
03.2019 - 10.2022
- Led deployment and implementation of new company labeling software
- Successfully migrated all labeling raw data into new software
- Participated in team projects, demonstrating ability to work collaboratively and effectively
- Assessed inefficiencies in production using labeling software to devise solutions and improve performance.
- Designed and procured label stocks, patient implant cards, IFUs, and product packaging
- Developed and improved all labeling and IFU procedures and processes
- Provided leadership to design and content of every product label and IFU.
- Collaborated with vendors to translate IFU and labeling content
Engineering Logistics Specialist
Cook Biotech Incorporated
12.2015 - 03.2019
- Authored, edited, and proofread quality system and manufacturing documents.
- Processed and monitored change requests using product life cycle management system
- Employed good documentation practice and technical writing skills to create and proofread instructions for use, marketing materials, and training materials
- Circulated design documentation for timely management approvals
- Communicated engineering project updates to affected departments
Education
Bachelor of Science - Business Management
Western Governors University
Indianapolis, IN01.2018
Skills
- Project management
- Strategic problem solver
- Expertise in ISO standards compliance
- System implementation
- Coaching and mentoring
- Independently motivated
- Precise technical content creation
- Change implementation
- Quality improvement initiatives
- Effective time management
- Clear and concise communication
- Strong focus on accuracy
Technical Proficiencies
- enLabel Global Services
- Loftware NiceLabel
- Prisym ID
- Microsoft (Outlook, Teams, Word, Excel, PowerPoint, Visio, Sharepoint, OneNote)
- Adobe (Acrobat, InDesign, Illustrator, Photoshop)
- Master Control Quality Management System
- Agile Product Lifecycle Management
- SAP Manufacturing Execution System
- EtQ Reliance
- Planview Project Place
- Asana
- Smartsheet
- Confluence
Timeline
Senior Labeling Project Manager
Acolad
02.2025 - Current
Labeling Project Manager
Globus Medical
10.2022 - 02.2025
Senior Product Labeling Specialist
Cook Biotech Incorporated
03.2019 - 10.2022
Engineering Logistics Specialist
Cook Biotech Incorporated
12.2015 - 03.2019
Bachelor of Science - Business Management
Western Governors University