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>Profile: Record to Reporting (R2R)</li><li>Performing financial reporting and controlling for across all the entities (in Hyperion and Oracle = JD Edward).</li><li>Performing End to End P&L finalization (Review of accruals, Negative Cash Accrual, prepaid amortization schedule, FX Adjustments, creation, deletion and capitalization of fixed assets, posting of depreciation etc.) & taking calls with Controllers during Months end for further review of P&L.</li><li>Banking process includes positive pay exceptions, stop payment, voiding checks with AP team. Checks movement to unclaimed property. Payment proof, remittance details.</li><li>IFRS lease computation complying with IFRS 16 in CoStar – Real Estate Manager system (this is only for lease).</li><li>Preparation of webforms and variance analysis report and sharing with stakeholders with detailed information.</li><li>Performing Balance sheet reconciliation with adherence of policy and clearance of open items along with relevant details of lines which is overaged however will be staying for long time (i.e.- Bonus and dividends, Common Stocks, Security Deposits).</li><li>Facilitating team operations by discussions through the sharing of information and knowledge, identification of teamwork issues, development of problem-solving recommendations, and recommendations of standardizing team operations.</li><li>Cross train resources in order to have backup of each other to help team synergy helping team members to take leaves when required without bothering of work/process deliverables.</li><li>Conduct weekly, biweekly and monthly meetings with stake holders as per their agreement.</li><li>Create opportunities for team members to provide input on procedures/processes and share their expertise with other team members.</li><li>Working knowledge of ERP systems People Soft, ART (Reconciliation software of Oracle), JD Edward, Teradata, Cetova, Hyperion (HFM), Cadency, Blackline, SAP, NetSuite, Workday Adaptive, Coupa, Tableau, CoStar, Alteryx.</li><li>PROCESS IMPROVEMENTS</li><li>Given 12 lean ideas in area of Month End Close journals, Balance Sheet Reconciliations, and Bank Reconciliations.</li><li>Part of a green belt project on quality of reconciliations and BOT implementation (work in progress) – controllership impact</li><li>Bring automation & Marco enabling dash board MIS reporting for monthly SLA, KPI, IC balances, Cash forecasting etc.</li></ul> at Genpact India Pvt. Ltd<ul><li>Profile: Record to Reporting (R2R)</li><li>Performing financial reporting and controlling for across all the entities (in Hyperion and Oracle = JD Edward).</li><li>Performing End to End P&L finalization (Review of accruals, Negative Cash Accrual, prepaid amortization schedule, FX Adjustments, creation, deletion and capitalization of fixed assets, posting of depreciation etc.) & taking calls with Controllers during Months end for further review of P&L.</li><li>Banking process includes positive pay exceptions, stop payment, voiding checks with AP team. Checks movement to unclaimed property. Payment proof, remittance details.</li><li>IFRS lease computation complying with IFRS 16 in CoStar – Real Estate Manager system (this is only for lease).</li><li>Preparation of webforms and variance analysis report and sharing with stakeholders with detailed information.</li><li>Performing Balance sheet reconciliation with adherence of policy and clearance of open items along with relevant details of lines which is overaged however will be staying for long time (i.e.- Bonus and dividends, Common Stocks, Security Deposits).</li><li>Facilitating team operations by discussions through the sharing of information and knowledge, identification of teamwork issues, development of problem-solving recommendations, and recommendations of standardizing team operations.</li><li>Cross train resources in order to have backup of each other to help team synergy helping team members to take leaves when required without bothering of work/process deliverables.</li><li>Conduct weekly, biweekly and monthly meetings with stake holders as per their agreement.</li><li>Create opportunities for team members to provide input on procedures/processes and share their expertise with other team members.</li><li>Working knowledge of ERP systems People Soft, ART (Reconciliation software of Oracle), JD Edward, Teradata, Cetova, Hyperion (HFM), Cadency, Blackline, SAP, NetSuite, Workday Adaptive, Coupa, Tableau, CoStar, Alteryx.</li><li>PROCESS IMPROVEMENTS</li><li>Given 12 lean ideas in area of Month End Close journals, Balance Sheet Reconciliations, and Bank Reconciliations.</li><li>Part of a green belt project on quality of reconciliations and BOT implementation (work in progress) – controllership impact</li><li>Bring automation & Marco enabling dash board MIS reporting for monthly SLA, KPI, IC balances, Cash forecasting etc.</li></ul> at Genpact India Pvt. Ltd