Open To Work
Katina Allen
Quality Manager
Youngsville,NC
Summary
Results-driven Quality Systems and IT Compliance professional with extensive experience leading moderately complex projects, managing GxP-compliant systems, and overseeing global Quality Management Systems (QMS) in highly regulated pharmaceutical and manufacturing environments. Demonstrated expertise in authoring and owning change controls, CAPA management, and document lifecycle oversight. Skilled in cross-functional leadership, process optimization, and end-to-end regulatory compliance. Advanced proficiency in eQMS/eDMS platforms, workflow automation, and IT tools, with a proven track record of improving operational efficiency, audit readiness, and inspection preparedness. Recognized for mentoring colleagues, facilitating agreements across teams, and driving continuous improvement initiatives.
Overview
20
20
years of professional experience
Work History
IT Project Manager, R&D PMO
Merz Aesthetics
Raleigh, NC
12.2023 - 08.2025
•Led end-to-end delivery of software solutions for medical device systems, aligning project scope with business needs.
•Developed, executed, and managed projects of varying complexity, ensuring on-time delivery.
•Authored and reviewed project documentation including change controls and validation protocols.
•Implemented workflow automation and KPI dashboards to improve operational efficiency.
•Coordinated multi-workstream project delivery and acted as liaison between R&D, Quality, and Engineering.
•Mentored team members and provided directional feedback.
Global Quality Manager, R&D Process and Learning Management
Merz Aesthetics
Raleigh, NC
05.2022 - 12.2023
•Owned and managed global CAPA and change control processes, supporting audit readiness.
•Led global quality governance, developing SOPs, standards, and best practices.
•Served as document sponsor/administrator for SOP reviews and e-system updates.
•Chaired SOP Committee and conducted training for global QMS users.
•Supported audit and inspection activities and performed root cause analyses.
Global Quality eSystems Manager
MARKEN, LLC
Durham, NC
10.2021 - 04.2022
•Oversaw global QMS compliance, document control, CAPA, and change control processes.
•Authored and approved controlled documents including SOPs and specifications.
•Monitored QMS performance metrics and improved change control cycle time.
•Chaired Quality Council meetings and reported global quality metrics.
Corporate Quality Manager
Burt's Bees Inc.
Durham, NC
01.2019 - 10.2021
•Managed global QA and OTC compliance across manufacturing functions.
•Led ERP quality system integration and real-time reporting improvements.
•Oversaw deviations, CAPAs, and batch release processes.
•Liaised between manufacturing sites and corporate QA for GMP compliance.
•Improved documentation readiness for audits and inspections.
Education
Bachelor of Science - Business Management
Skills
- CAPA, Change Control & Audit Response
- GxP Compliance (GMP, GCP, GLP), FDA 21
- eQMS / eDMS Implementation (MasterControl, Veeva Vault, CARA, ZenQMS, Intelex)
- Software/System Implementation & Validation
- Document Control, Training Management & Quality Oversight
- Cross-Functional Leadership
- Critical & Strategic Thinking
- Team Mentorship & Coaching
- Problem Solving & Root Cause Analysis, Risk Management, Failure Mode Effect Analysis
- Communication & Stakeholder Management
- Continuous Improvement & Operational Readiness
- Advanced IT & Analytical Skills (MS Office, MS Project, Smartsheet, Visio, JIRA, Tableau)
- Experience with compliance & regulatory standards (FDA, ISO, GxP)
Affiliations
- Zeta Phi Beta Sorority, Incorporated, 2020
- American Society for Quality (ASQ), 2016
- Personal Care Products Council (PCPC), 2020
Timeline
IT Project Manager, R&D PMO - 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
North Carolina Wesleyan University - Bachelor of Science, Business Management