Hiking
DEBORAH STOWE, PMP
Ladera Ranch,CA
Summary
Methodical director with 18+ years of comprehensive experience overseeing all aspects of Quality Systems implementation, validation, change management and ongoing compliance. Hardworking and versatile professional well-versed in GxP System compliance and data integrity. Thorough knowledge of compliance regulations and validation trends paired with strong grasp of corporate finance and performance measures.
Overview
18
18
years of professional experience
1
1
Certificate
Work History
Director, Computer Systems Validation
Mirati Therapeutics-Bristol Myers Squibb
San Diego , CA
2024.01 - Current
- Provides oversight of computer system validation and e-compliance programs.
- Liaises with Quality Systems, Quality Assurance, and IT departments to ensure comprehensive review and oversight of GxP computer systems, while providing validation support for system implementation, upgrades, and enhancements.
- Responsible for software quality oversight and execution of system validation and verification efforts supporting computerized systems, including equipment and instruments with a computer component, to ensure compliance with quality objectives and regulatory requirements.
- Provides QA and validation leadership for GxP computerized systems, applying a risk-based methodology to validation and qualification efforts in compliance with 21 CFR Part 11 and EU Annex 11, or equivalent international regulations.
- Design, implement, and govern the overall readiness of Computer System Validation and Data Integrity programs to ensure systems are compliant and ready for regulatory inspections.
- Provides oversight and execution of validation strategy in support of configured software systems, workflow, and analytics to improve the overall accuracy, efficiency, and effectiveness of the electronic computerized systems.
- Assesses systems for data integrity and compliance with regulatory expectations, including assessment of third-party service suppliers and applications.
- Effectively identifies and resolves complex system issues and appropriately communicates gating of critical items to senior management and stakeholders.
- Provides quality review, risk assessment, and approval of deviations, CAPAs, change controls, and other quality events.
- Assists in the external audit program to ensure compliance of vendors involved with GxP computerized systems.
- Provides inspection readiness training and acts as backroom manager.
- Implemented AuditUtopia Inspection Readiness software and provided system administration and end user training.
Associate Director, Computer Systems Validation
Mirati Therapeutics-Bristol Myers Squibb
San Diego , CA
2021.09 - 2023.12
- Provides oversight of computer system validation and e-compliance programs.
- Liaises with Quality Systems, Quality Assurance, and IT departments to ensure comprehensive review and oversight of GxP computer systems, while providing validation support for system implementation, upgrades, and enhancements.
- Responsible for software quality oversight and execution of system validation and verification efforts supporting computerized systems, including equipment and instruments with a computer component, to ensure compliance with quality objectives and regulatory requirements.
- Provides QA and validation leadership for GxP computerized systems, applying a risk-based methodology to validation and qualification efforts in compliance with 21 CFR Part 11 and EU Annex 11, or equivalent international regulations.
- Design, implement, and govern the overall readiness of Computer System Validation and Data Integrity programs to ensure systems are compliant and ready for regulatory inspections.
- Provides oversight and execution of validation strategy in support of configured software systems, workflow, and analytics to improve the overall accuracy, efficiency, and effectiveness of the electronic computerized systems.
- Assesses systems for data integrity and compliance with regulatory expectations, including assessment of third-party service suppliers and applications.
- Effectively identifies and resolves complex system issues and appropriately communicates gating of critical items to senior management and stakeholders.
- Provides quality review, risk assessment, and approval of deviations, CAPAs, change controls, and other quality events.
- Assists in the external audit program to ensure compliance of vendors involved with GxP computerized systems.
- Provides inspection readiness training and acts as backroom manager.
- Implemented AuditUtopia Inspection Readiness software and provided system administration and end user training.
Sr. Manager, Quality Systems
Pacira Pharmaceuticals
San Diego , CA
2018.06 - 2021.09
- Responsible for the strategic development, implementation, and management of the global Quality Management System (EDMS/QMS, LMS), which supports the manufacturing and testing of clinical and commercial aseptic drug products in compliance with applicable regulatory requirement
- Managerial oversight of the Quality Systems Department, including Quality Systems, Document Control, and GxP Training functions utilizing MasterControl EDMS/QMS and ComplianceWire LMS.
- Monitored performance of MasterControl EDMS/QMS, implemented and validated software upgrades, and implemented process improvement initiatives to ensure effectiveness, efficiency, and ongoing regulatory compliance.
- Developed, implemented, and managed QMS metrics, project dashboards, and department plans.
- Automated CAPA Quality process and partnered with business owners to enhance automated Quality processes to improve efficiency and compliance.
- Developed inspection management process and provided system administration of the inspection management system.
- Participated on Change Control Board to assess impact of upgrades, enhancements, and bug fixes for all Global GxP systems to ensure ongoing compliance.
- Organized and developed semi-annual GMP trainings globally for all manufacturing sites.
- Coordinated and provided oversight of Quarterly management review.
- Global Quality representative for computer system validation of GxP systems.
- Provided inspection readiness training and backroom support for regulatory inspections.
- Liaising across business units to build relationships, remove silos, train, and support system end users with EDMS/QMS and GXP compliance processes, policies, and procedures.
IS Compliance Support
Nexgen Pharma
Irvine , CA
2017.02 - 2018.06
- Responsible for building an IS Compliance program, which included the implementation, validation, and administration of all FDA-regulated systems.
- Established practices to ensure data integrity of Quality systems by performing gap analysis/audits of existing laboratory and Quality systems and audit log reviews. Developed and maintained application security matrices and authored SOPs to govern system usage and administration, ensuring continued compliance of systems under change control.
- Performed system administration of MasterControl QMS, Biovia LES-LIMS, and ARIM eCTD publishing systems.
Quality Systems Manager
Nexgen Pharma
Irvine , CA
2015.01 - 2017.02
- Managerial responsibilities included overseeing the QMS, EDMS and Project Management groups.
- Provided project management for the implementation and validation of complex systems for the Quality and Regulatory groups to ensure FDA compliance, as well as project team member for implementation of Track and Trace system and ERP system implementations.
- Provided project management for the implementation, validation, and administration of MasterControl QMS, Biovia LES-LIMS systems, and ARIM eCTD Publishing Systems, ensuring continued validation and proper change control, end user training, and day-to-day support and administration of the systems.
- Authored system administration SOPs, validation protocols, and reports.
- Collaborated with the Quality units to automate and enhance Quality processes (Non-Conformances, Deviations, Complaints, CAPAs).
- Authored SOPs for automated Quality processes.
- Reported KPI metrics and identified trends for Quarterly Quality Review.
- Provided end-user support and training.
- Acted as a liaison between software vendors and end users to resolve technical issues.
- Coordinated and lead weekly and quarterly Quality Reviews.
Electronic Document Control System Administrator
Nexgen Pharma
Irvine , CA
2008.11 - 2015.01
- Managerial responsibilities included overseeing the daily activities of the Document Control group, including document review, task allocation, and special projects.
- Responsible for system implementation, validation, and administration of MasterControl QMS, EDMS, ARIM eCTD Publishing Software, and Biovia LES-LIMS systems, and ensured continued compliance and change management.
- Provided system administration, support, and end-user training.
- Responsible for authoring system-related policies, validation protocols, and reports.
Quality Systems Consultant
Stowe & Associates
Orange County , CA
2006.03 - 2008.11
- Consulted with various pharmaceutical clients, including Watson Pharmaceutical, Allergan, and Nexgen Pharma.
- Assisted in the implementation and validation of electronic document management systems
- Performed QA reviews for qualification protocols and SOPs
- Conducted examination, classification, organization, and verification of data records stored in an electronic repository compared to paper-based records.
Education
Bachelor of Science in Business Administration - Accounting -
Robert Morris University
Pittsburgh, PASkills
- cGxP
- 21 CFR 11
- Annex 11
- GAMP 5
- CSA
- Computer System Validation (CSV)
- Staff Management
- Quality Systems (QMS, EDMS, LMS)
- Change Control
- Data Integrity
- Project Management
- FDA Inspection support
- FDA Inspection Readiness Training
- GMP Training
- Process Improvement
- Risk and Impact Assessments
- Project Management
- Quality Systems (QMS, EDMS, LMS)
- Veeva Vault
- MasterControl
- ComplianceWire
- Critical Thinker
- Verbal Communication
- Written Communication
- Interpersonal Skills
- Organization
Certification
Project Management Professional (PMP)
Systems
- MasterControl Quality Management System (Member of Customer Advisory Board 2012 - 2018)
- Compliance Wire LMS
- Biovia LES-LIMS
- ACUTA ARIM eCTD Publisher Software
- Liquent S-Cubed eCTD
- Veeva QDocs/QMS
- AuditUtopia
Timeline
Director, Computer Systems Validation
Mirati Therapeutics-Bristol Myers Squibb
2024.01 - Current
Associate Director, Computer Systems Validation
Mirati Therapeutics-Bristol Myers Squibb
2021.09 - 2023.12
Sr. Manager, Quality Systems
Pacira Pharmaceuticals
2018.06 - 2021.09
IS Compliance Support
Nexgen Pharma
2017.02 - 2018.06
Quality Systems Manager
Nexgen Pharma
2015.01 - 2017.02
Electronic Document Control System Administrator
Nexgen Pharma
2008.11 - 2015.01
Quality Systems Consultant
Stowe & Associates
2006.03 - 2008.11
Bachelor of Science in Business Administration - Accounting -
Robert Morris University
- Project Management Professional (PMP)
Interests
CrossFit
Cooking
References
References available upon request.
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