Courtney Stafford
Summary
Experienced pharmaceutical quality professional with a strong background in regulatory compliance, quality assurance, and process improvement. Demonstrated expertise in procedural document management and authoring, inspections, CAPA process management, and delivering effective training programs. Exceptional organizational skills and attention to detail, consistently ensuring adherence to industry standards and regulations.
Overview
22
22
years of professional experience
Work History
Senior Quality Manager, Global Development Process and Procedures
Regeneron Pharmaceuticals
12.2023 - 01.2025
- Managed quality reviews of Global Development procedural documents within Veeva Vault
- Improved document review efficiency through streamlined process
- Led inspection management activities that contributed to successful inspections
- Provided oversight to Quality Managers and Document Coordinators
- Ensured periodic reviews are completed for procedural documents
- Tracked CAPA requirements to completion
- Evaluated metrics on procedural documents and provide continuous improvements for procedural documents
- Mentored junior team members to enhance their understanding of quality management principles and drive a culture of continuous improvement.
- Achieved departmental objectives by setting clear performance metrics and regularly reviewing progress against targets.
Quality Manager, Global Development Process and Procedures
Regeneron Pharmaceuticals
01.2021 - 12.2023
- Performed quality review of procedural documents.
- Managed workflows and conducted periodic reviews to ensure accuracy and compliance with regulatory standards.
- Tested system requirements for Veeva Vault implementation.
- Collected procedural document metrics.
- Supported inspection management activities.
Operations Manager, Global Development Process and Procedures
Regeneron Pharmaceuticals
06.2014 - 12.2020
- Developed, revised and managed procedural documents with functional subject matter experts
- Prepare and route procedural documents and performance tools through the approval process using the electronic document compliance system
- Participated in cross functional study teams and/or sub-teams within Global Development
- Develops reports to support tracking of inspection readiness activities based on Regulatory Inspection Guides and planned actions
Senior Technical Writer and Compliance Specialist
Novartis Pharmaceuticals
11.2011 - 06.2014
- Led and managed deviations and investigations for Engineering/Facilities via Trackwise
- Identified root cause during investigations and assigned the appropriate CAPA
- Monitored and tracked CAPAs to ensure completion
- Identified procedural gaps and implemented improvements with preparation and administration of Standard Operating Procedures (SOP)
- Prepared and routed documents for review and approval through document management system
- Reported monthly metrics/trend analysis to Site Management
- Participated and supported internal and external audits
- Facilitated training as a Qualified Trainer
Compliance Training Specialist
Pfizer
06.2008 - 11.2010
- Designed, developed, rolled out and coordinated series of training to employees across the organization to ensure that correct processes and software were utilized correctly and efficiently
- Developed role-based curriculum within Learning Management Software (LMS) to ensure curriculum was consistent and aligned for job functions
- Scheduled, delivered, documented, and tracked training completion on procedures, on-the-job, safety and computer-based training which met compliance requirements and increased training completion among employees
- Reviewed conformance standards for gap analysis and interfaced with subject matter experts to improve curriculum requirements and improve training requirements
- Led train-the-trainer, pilot and implementation training classes, resulting in increased usage and adherence of regulations
Training Specialist III
Wyeth Pharmaceuticals
06.2003 - 06.2008
- Recognized for high performance of position which led to expanding the role from a Biotech QA trainer position, to one that includes regulatory, as well as site leadership and site partnership sites.
- Collaborated with department heads to identify training needs and align programs with organizational goals.
- Created comprehensive training materials for new hires to enhance understanding of company policies and procedures.
- Improved compliance by raising individual training percentage over ten percent by partnering with senior managers to increase accountability and create a rigorous course schedule for employees.
- Delivered a broad spectrum of trainer programs, which included Annual GMP topics, SOP, Investigation, Diversity and Management training.
- Led and collaborated with trainers from various parts of the site to create a global training forum to discuss upcoming training courses that needed to be delivered.
Education
Bachelor of Science -
University of Maryland
05.2002
Skills
- Veeva Vault
- Trackwise
- DocCompliance
- Microsoft Office Suite
- Microsoft Teams
- SharePoint
- Visio
- Corrective and preventive actions
- CAPA investigations
- Quality metrics development
- SOP development
Timeline
Senior Quality Manager, Global Development Process and Procedures
Regeneron Pharmaceuticals
12.2023 - 01.2025
Quality Manager, Global Development Process and Procedures
Regeneron Pharmaceuticals
01.2021 - 12.2023
Operations Manager, Global Development Process and Procedures
Regeneron Pharmaceuticals
06.2014 - 12.2020
Senior Technical Writer and Compliance Specialist
Novartis Pharmaceuticals
11.2011 - 06.2014
Compliance Training Specialist
Pfizer
06.2008 - 11.2010
Training Specialist III
Wyeth Pharmaceuticals
06.2003 - 06.2008
Bachelor of Science -
University of Maryland