Katina Allen
Corporate Global Manager
Youngsville,NC
Summary
Hardworking, reliable professional with profound knowledge in quality assurance, QMS, IT, ICH, and GxP, who is proficient in driving initiatives and process improvements. Prepared and willing to contribute effectively to the organization's overall business goals.
Overview
9
9
years of professional experience
Work History
R&D IT Manager, Project Management Organization
Merz Aesthetics
Raleigh, NC
12.2023 - 08.2025
- Support R&D organization from technical and business process perspectives.
- Ensure compliance with computer system validation and administration.
- Implement and manage R&D applications and support all R&D business units.
- Develop validation test scripts and guide UAT execution.
- Manage user permissions and perform access verifications.
- Resolve issues and coordinate with vendors for system enhancements.
- Oversaw IT department operations and training.
- Managed network and system performance, conducting troubleshooting, security patching, and maintenance.
Global Quality Manager, R&D Process and Learning Management
Merz Aesthetics
Raleigh, NC
05.2022 - 12.2023
- Managed R&D training compliance and quality oversight aligned with QMS.
- Maintained training documentation and metrics reporting.
- Supported SOPs, CAPAs, deviations, and system validation.
- Led harmonization initiatives and compliance improvement projects.
- Monitored regulatory updates to ensure policy compliance.
- Supported regulatory inspections and audits.
Global Quality eSystems Manager
MARKEN, LLC
Durham, NC
10.2021 - 04.2022
- Oversaw global QMS and compliance across clinical trial distribution.
- Led document control, CAPA processes, audits, and system training.
- Managed global quality associates and facilitated cross-functional collaboration.
- Ensured compliance with CFR 21 Parts 11, 210, 211, 803, 820, and ICH Q7.
- Delivered QMS metrics and chaired quarterly Quality Council meetings.
Corporate Quality Manager
Burt's Bees Inc.
Durham, NC
01.2019 - 10.2021
- Led global quality assurance and OTC compliance initiatives.
- Managed product release, stability testing, and third-party oversight.
- Supported international markets and led eQMS improvements.
- Participated in DEI initiatives and employee resource groups.
Corporate Quality Specialist
Burt's Bees Inc.
Durham, NC
10.2017 - 01.2019
- Managed complaint handling, CAPAs, and product lot release.
- Conducted risk assessments and coordinated annual product reviews.
- Led internal audits and ensured regulatory compliance.
Corporate Document Control Coordinator
Burt's Bees Inc.
Durham, NC
10.2016 - 10.2017
- Maintained controlled documents and supported lot release verification.
- Administered training systems and audit schedules.
Education
Bachelor of Science - Business Management
North Carolina Wesleyan University
Skills
- Leadership and Personnel Management
- R&D applications
- Computer system validation
- Quality management systems
- User acceptance testing
- Regulatory compliance
- Project management
- Cross-functional collaboration
- Process improvement
- Document control
- Risk assessment
- Problem solving
- Effective communication
- Team leadership
- IT risk management
- Quality assurance
- Documentation management
- Critical and Strategic Thinking
- Team Building and Collaboration
- Risk Management
- GxP
- Budget Planning & Cost Control
- Improvement and Release Strategies
- Supplier Relationship Management
- Training & Development
- Process & Learning Management
- EQMS
- EDMS
- JIRA
- ETMF
- Drug Track
- CTMS
- CARA
- EQMS: Intelex eQMS
- ZenQMS
- Master Control
- PowerBI
- SharePoint
- Teams
- WebEx
- ServiceNow
- Application Support
- Success Factors LMS
- Minitab
- Tableau
- Visio
- Ultipro
- Concur
- Smartsheet
- Coupa
- MyBuy
- IT resource use
- Change management
- Risk mitigation planning
- IT compliance
- Documentation and reporting
Affiliations
- Zeta Phi Beta Sorority, Incorporated, 2020
- American Society for Quality (ASQ), 2016
- Personal Care Products Council (PCPC), 2020
Timeline
R&D IT Manager, Project Management Organization
Merz Aesthetics
12.2023 - 08.2025
Global Quality Manager, R&D Process and Learning Management
Merz Aesthetics
05.2022 - 12.2023
Global Quality eSystems Manager
MARKEN, LLC
10.2021 - 04.2022
Corporate Quality Manager
Burt's Bees Inc.
01.2019 - 10.2021
Corporate Quality Specialist
Burt's Bees Inc.
10.2017 - 01.2019
Corporate Document Control Coordinator
Burt's Bees Inc.
10.2016 - 10.2017
Bachelor of Science - Business Management
North Carolina Wesleyan University