Katherine Johnson
Saint Paul,MN
Summary
Business Professional with over 15 years of expertise in Quality & Compliance, Project Management, and Team Management across diverse sectors including Automotive, Medical/Life Sciences, IT, Financial, and Legal markets. Proven track record in developing ISO-compliant quality management systems and conducting audits while maintaining compliance with regulations such as FWA, HIPAA, and CCPA. Strong leadership in managing both local and global teams to meet tight project timelines while fostering effective communication and conflict resolution. Veteran Program Manager skilled in overseeing business operations and implementing cost control initiatives to enhance overall efficiency.
Overview
15
15
years of professional experience
1
1
Certificate
Work History
Sr. Manager of Quality & Compliance
PGLS
01.2023 - 06.2024
- Plan and manage audits for ISO certifications
- Implement a QMS and maintain compliance
- Create and manage CAPA process
- Support departments in developing quality control procedures
- Initiate and support process improvements for all company departments
- Ensure QMS is modified according to company growth
- Implemented FWA training program and company-wide annual training
- Built a QMS from scratch and built the DMS that included all business units of the company
- Identified and implemented/built a QMS system for compliance and scalability
- Implemented and managed training programs of new employees and annual required trainings
- Managed internal and external audits
- Built a QMS that started compliant for under 50 people and ending in a total of 140 employees within 13 months of my employment
- Implemented risk management and FMEA policies and tracking
- Instituted a quarterly CAPA board meeting and bi-annual management review meetings
- Established quality objectives to support company business objectives within the QMS and annual review meetings with leadership
- Wrote and published the company’s first quality manual
- Completed full gap analysis for ISO 13485 and 17100 and roadmap for ISO achieving certifications
Localization Program Manager
ISI Language Solutions – a BIG Language Company
04.2022 - 11.2022
- Oversaw a client base with a total revenue of $10 million
- Managed a team of ten Project Managers (PM)
- Identified process gaps and implemented formal DTP and QC steps and guidelines into the workflow
- Built a Project Coordination team and process so Project Managers were a part of each function
- Identified support gaps and advocated to get additional team members hired for support
- Built and executed a training process for the entire team so every client had multiple fully-trained members to support influx in volume and knowledge distribution
- Took on a 20-client list with no assigned PMs
- I assigned a dedicated PM to the accounts so that client needs had ownership and so historical knowledge could be built
- Previously this work changed monthly and no knowledge was documented
- The standardization steps I put in place, saw an increase in volume with my client base with two large clients tripling their volume in a span of a few months
- Developing a clear, standard operations process
- Cleaning up quality of our deliverables so that all major clients under my purview doubled or tripled their volume
Director of Client Services
SmartBase Solutions
Minneapolis, MN
11.2017 - 08.2021
- Managed a team of six consisting of Customer Service and Project and Account Managers
- Managed two different business units within the company consisting of Marketing Automation focused on the medical industry and a Loyalty Rewards program for franchisees with over $2.8 million in revenue
- Documented processes and implemented SOPs
- Owned and managed the program improvement roadmap and coordinate priorities with the CIO and President
- Managed program improvement and management of Patient Advocate programs with Medtronic
- Communicated directly with clients to make sure their needs are being met and issues resolved
- Created and documented SOPs for my clients
- Implemented the first localized Patient Support Program for Latin America
Quality Systems Lead
United Language Group (ULG (formerly Merrill Brink International))
Minneapolis, MN
05.2017 - 11.2017
- Responsible for CAPA management, investigating quality issues and working with Operations Teams across the business on corrective actions
- Audit and manage processes and ensuring adherence to ISO 9001:2015, 13485 (med device standard) and 17001 (translations standard)
- Identify Corrective and Preventative Actions and see through the implementation and Verification of Effectiveness
Manager of US Legal Operations, (2016-2017), Manager of Project Coordination and Desktop Publishing (2015-2016)
United Language Group (ULG (formerly Merrill Brink International))
Minneapolis, MN
05.2015 - 05.2017
- Responsible for hiring, training, mentoring and management of over 30 individuals across the Project Managers (PMs), Coordinators (PCs) and Desktop Publishing (DTP) teams
- Managed the global process and standards of global Legal team of 15 PMs and PCs in New York, Minneapolis, Galway, Mumbai and Hong Kong
- Identified and monitor opportunities to improve process and margins to meet financial goals
- Worked directly with our clients, pricing and sales teams on new business opportunities and client relations
- Documented Quality, DTP, PCs and PMs SOPs to ensure SOPs teams follow and in line with ISO certifications
- Training and establishing the Legal team
- Established guidelines for top 50 clients, empowering our global teams to accurately address needs of clients
- Created training programs for PM, PC and DTP Coordinators
- Management of cost initiatives and vendor spending bringing our profit margins to a standard 65%
Project Manager (2011-2015), Project Coordinator (2009-2011)
Merrill Brink International (c/o Merrill Corporation)
Saint Paul, MN
02.2009 - 05.2015
- Led multiple high profile and complex localization projects while providing technical and tactical expertise to Fortune 500 company clients in a deadline driven production environment
- Consulted on technical software automation needs, identifying process issues and implemented solutions
- Partnered with IT to develop automation for Across software and train internal resources
- Constructed detailed status reports, budgets, project kick-off presentations and planning matrixes
- Worked with internal and external teams to ensure client’s requirements were met
- Developed infrastructure for Medical Claims translations
- Developed training program and trained PCs, PMs, and linguistic resources on medical claims process
- Managed the transition and IT development of new Across content management system for $2 million client
- Managed $2 million in projects for new election services account in a three-month span
Education
Certified Professional Project Manager -
St. Thomas University
Minneapolis, MNBachelor of Arts - Global Studies and International Journalism
Hamline University
Saint Paul, MNSkills
- Certified Professional Project Manager (CPPM)
- Microsoft Office Suite
- Google Workspace
- Translation Management Systems
- Docu-Proof
- HR/Business platforms: ADP, Concur, Kronos
- SharePoint
- Sugar OKR Sofware
- Ebility
- Traction
- Skilled in TMS and QMS Utilization
- Quality Management Software Expertise
- Project Management Tools and Tracking Solutions
- Spanish
- Compliance and Regulatory Knowledge
- Internal and External Auditing
Timeline
Sr. Manager of Quality & Compliance
PGLS
01.2023 - 06.2024
Localization Program Manager
ISI Language Solutions – a BIG Language Company
04.2022 - 11.2022
Director of Client Services
SmartBase Solutions
11.2017 - 08.2021
Quality Systems Lead
United Language Group (ULG (formerly Merrill Brink International))
05.2017 - 11.2017
Manager of US Legal Operations, (2016-2017), Manager of Project Coordination and Desktop Publishing (2015-2016)
United Language Group (ULG (formerly Merrill Brink International))
05.2015 - 05.2017
Project Manager (2011-2015), Project Coordinator (2009-2011)
Merrill Brink International (c/o Merrill Corporation)
02.2009 - 05.2015
Certified Professional Project Manager -
St. Thomas University
Bachelor of Arts - Global Studies and International Journalism
Hamline University
Certification
- ISO 9001:2015
- ISO 31000 Risk Management
- Certified Professional Project Manager (CPPM)
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