Summary
Overview
Work History
Education
Skills
Affiliations
Timeline
Generic

KATINA ALLEN

Youngsville,NC

Summary

Results-oriented R&D IT Manager at Merz Aesthetics, showcasing a solid background in quality management systems and regulatory compliance. Expert in computer system validation and cross-functional collaboration, driving process improvements that enhance operational efficiency. Passionate about leading teams to achieve excellence and ensuring adherence to industry standards.

Overview

17
17
years of professional experience

Work History

R&D IT Manager, Project Management Organization

Merz Aesthetics
Raleigh, NC
12.2023 - Current
  • 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.

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.

Corporate Complaints Coordinator

Axelon c/o Burt's Bees Inc.
Durham, NC
05.2016 - 10.2016
  • Handled global complaints and adverse events.
  • Conducted risk assessments and supported international quality certifications.

Quality Expert Supervisor

Research Triangle Institute
RTP, NC
04.2010 - 05.2016
  • Managed data collection teams and ensured adherence to client protocols.
  • Delivered high-quality services and maintained strong client relationships.

Data Collection Specialist

Research Triangle Institute
RTP, NC
04.2008 - 04.2010
  • Conducted national research studies for CDC, DOE, and DOJ.
  • Ensured data accuracy and compliance with study protocols.

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 - Current

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

Corporate Complaints Coordinator

Axelon c/o Burt's Bees Inc.
05.2016 - 10.2016

Quality Expert Supervisor

Research Triangle Institute
04.2010 - 05.2016

Data Collection Specialist

Research Triangle Institute
04.2008 - 04.2010

Bachelor of Science - Business Management

North Carolina Wesleyan University

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