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
Postdoctoral Fellow at Regeneron Genetic Center, Regeneron Pharmaceuticals, Inc.Postdoctoral Fellow at Regeneron Genetic Center, Regeneron Pharmaceuticals, Inc.
<ul><li>Assist in preparing Subs Annual Budgets and reviewing Subs financial reports.</li><li>Provide support and training to partners to ensure adequate support for the program component.</li><li>Conduct partner technical supportive supervision on request basis from Grants & Compliance teams.</li><li>Coordinate grantee proposal review process and ensure compliance with solicitations and donor regulations.</li><li>Coordinate pre-award evaluations and assessments of potential grantees as needed.</li><li>Analyze, verify and review grantees proposal budgets to ensure donor compliance and reasonableness.</li><li>Coordinate the assessment of grantee risk and implement appropriate systems and agreements to minimize risk.</li><li>Ensure timely and appropriate close-out of sub-grants and coordinate the close-out of EGPAF prime grants.</li><li>Provide support and training to partners finance staff to build financial and accounting capacity to ensure adequate support for the program component.</li><li>Monitor partners’ spending patterns as part of the overall project budget to actual analytics.</li><li>Follow up on Grantee monthly invoices & supporting documents</li><li>Serve as an expert on applicable policies, procedures, rules, and regulations and assist staff with their interpretation and understanding of these.</li><li>Stays abreast of donor policies, procedures, rules and regulations and host country legal requirements and informs local and regional management of significant changes.</li><li>Perform internal departmental/grants reviews ensuring compliance with Foundation and donor requirements. Identify potential areas of compliance vulnerability and risk; assists with the development of corrective action plans for the resolution of problematic issues; and provides general guidance on how to avoid or deal with similar issues in the future</li><li>Conduct on-site financial compliance reviews which include: cash counts; review of accounts receivables including employee receivables; documentation of segregation of duties and internal control structure; document storage and retention</li><li>Document findings, propose improvements or change as relevant, disseminate findings and ensure follow up implementation of recommendations as well as resolution</li><li>Conduct random surprise checks and vendor verification reviews to ensure proper procurement procedures are being practiced and report on findings</li><li>Develops an effective Compliance & Ethics training program, including appropriate introductory training for new employees as well as ongoing training for all employees and managers</li><li>Assists with improving the awareness and understanding of compliance to assist employees with the establishment of a “culture of compliance”</li></ul> at Elizabeth Glaser Pediatric Aids Foundation<ul><li>Assist in preparing Subs Annual Budgets and reviewing Subs financial reports.</li><li>Provide support and training to partners to ensure adequate support for the program component.</li><li>Conduct partner technical supportive supervision on request basis from Grants & Compliance teams.</li><li>Coordinate grantee proposal review process and ensure compliance with solicitations and donor regulations.</li><li>Coordinate pre-award evaluations and assessments of potential grantees as needed.</li><li>Analyze, verify and review grantees proposal budgets to ensure donor compliance and reasonableness.</li><li>Coordinate the assessment of grantee risk and implement appropriate systems and agreements to minimize risk.</li><li>Ensure timely and appropriate close-out of sub-grants and coordinate the close-out of EGPAF prime grants.</li><li>Provide support and training to partners finance staff to build financial and accounting capacity to ensure adequate support for the program component.</li><li>Monitor partners’ spending patterns as part of the overall project budget to actual analytics.</li><li>Follow up on Grantee monthly invoices & supporting documents</li><li>Serve as an expert on applicable policies, procedures, rules, and regulations and assist staff with their interpretation and understanding of these.</li><li>Stays abreast of donor policies, procedures, rules and regulations and host country legal requirements and informs local and regional management of significant changes.</li><li>Perform internal departmental/grants reviews ensuring compliance with Foundation and donor requirements. Identify potential areas of compliance vulnerability and risk; assists with the development of corrective action plans for the resolution of problematic issues; and provides general guidance on how to avoid or deal with similar issues in the future</li><li>Conduct on-site financial compliance reviews which include: cash counts; review of accounts receivables including employee receivables; documentation of segregation of duties and internal control structure; document storage and retention</li><li>Document findings, propose improvements or change as relevant, disseminate findings and ensure follow up implementation of recommendations as well as resolution</li><li>Conduct random surprise checks and vendor verification reviews to ensure proper procurement procedures are being practiced and report on findings</li><li>Develops an effective Compliance & Ethics training program, including appropriate introductory training for new employees as well as ongoing training for all employees and managers</li><li>Assists with improving the awareness and understanding of compliance to assist employees with the establishment of a “culture of compliance”</li></ul> at Elizabeth Glaser Pediatric Aids Foundation
<ul>
<li>Assigned and reviewed daily net asset value calculations performed by Senior Fund Accountant.</li>
<li>Maintained accurate records of employee performance, attendance, leave requests, and disciplinary actions.</li>
<li>Tracked progress on projects and provided timely feedback to staff members.</li>
<li>Participated in recruitment efforts by interviewing prospective candidates for open positions.</li>
<li>Ensured timely and accurate responses to client inquiries, managing quality of deliverables.</li>
<li>Created staff allocation plans based on activity SLAs, assisting with internal and external queries.</li>
<li>Facilitated successful completion of new client onboarding and fund launches.</li>
<li>Reviewed administrative and accounting procedures, recommending solutions for efficient NAV production.</li>
<li>Provided leadership through training, coaching, and supervision of staff members.</li>
<li>Performed end-of-day reports and signed off on net asset valuations.</li>
<li>Monitored employee productivity levels on a regular basis to identify areas of improvement.</li>
<li>Directed and supervised team of 15 employees in daily operations.</li>
<li>Monitored employee productivity to provide constructive feedback and coaching.</li>
<li>Identified opportunities for process improvements, leading to cost reductions and increased productivity.</li>
<li>Resolved customer complaints and issues promptly, ensuring customer satisfaction and loyalty.</li>
</ul> at CIBC Mellon Global Securities Inc<ul>
<li>Assigned and reviewed daily net asset value calculations performed by Senior Fund Accountant.</li>
<li>Maintained accurate records of employee performance, attendance, leave requests, and disciplinary actions.</li>
<li>Tracked progress on projects and provided timely feedback to staff members.</li>
<li>Participated in recruitment efforts by interviewing prospective candidates for open positions.</li>
<li>Ensured timely and accurate responses to client inquiries, managing quality of deliverables.</li>
<li>Created staff allocation plans based on activity SLAs, assisting with internal and external queries.</li>
<li>Facilitated successful completion of new client onboarding and fund launches.</li>
<li>Reviewed administrative and accounting procedures, recommending solutions for efficient NAV production.</li>
<li>Provided leadership through training, coaching, and supervision of staff members.</li>
<li>Performed end-of-day reports and signed off on net asset valuations.</li>
<li>Monitored employee productivity levels on a regular basis to identify areas of improvement.</li>
<li>Directed and supervised team of 15 employees in daily operations.</li>
<li>Monitored employee productivity to provide constructive feedback and coaching.</li>
<li>Identified opportunities for process improvements, leading to cost reductions and increased productivity.</li>
<li>Resolved customer complaints and issues promptly, ensuring customer satisfaction and loyalty.</li>
</ul> at CIBC Mellon Global Securities Inc