Dawn Green
Philadelphia,PA
Summary
Dynamic Senior Director with extensive expertise in quality management and risk-based strategies. Adept at driving continuous improvement and fostering cross-functional alliances at all organizational levels. I effectively influence organizational culture while ensuring compliance with Good Clinical Practice (GCP). Committed to enhancing clinical trial quality through practical strategies that maintain inspection readiness, and promote a culture of compliance.
Overview
30
30
years of professional experience
1
1
Certification
Work History
Senior Director, Quality and Risk Management (QRM) - Oncology
GlaxoSmithKline (GSK)
Collegeville, PA
11.2016 - Current
- Advise GSK clinical development teams within the assigned therapeutic area on strategic approaches to quality and risk management.
- Influence all levels within the organization to foster a culture of, and commitment to, quality and risk management across GSK and third-party partners.
- Closely collaborate with sub-groups within R&D Quality and Risk Management, who oversee and perform internal and external audits, regulatory inspection support, risk and issue management, to provide input, develop quality and risk management strategies, and enhance the support of various functions, including audit planning, risk assessment, issue investigation, root cause analysis, and CAPA development.
- Identify and drive continuous quality improvements by leveraging knowledge and data gathered from risk assessments, audits, inspections, trends/metrics, and root cause analysis.
- Integrate Quality by Design principles into clinical development activities by educating relevant teams on Quality by Design methodologies and best practices.
- Analyze capability gaps to design a tailored quality and GCP compliance training curriculum that meets or exceeds capability requirements.
- Lead inspection readiness activities. Support the preparation, execution, and closeout of health authority regulatory inspections.
- Monitor the performance of Oncology R&D and external partners through the assessment of compliance and quality trends. Facilitate the implementation of quality improvements as required, and ensure that business-critical quality improvements are adequately resourced to deliver.
- Represent Oncology RD by providing strategic input regarding quality and risk management as a member of various cross-GSK R&D forums, including the Risk Management Community of Practice, Data Integrity Risk Council, Third Party Quality Review Committee, and Crisis and Continuity Management Network.
Good Clinical Practice (GCP) Compliance Senior Manager
Pfizer
Collegeville, PA
09.2015 - 10.2016
- Managed significant quality events (SQEs) identified by clinical development teams across programs in the conduct of global clinical trials.
- Formed SQE teams with appropriate stakeholders, business process owners, and facilitated SQE team meetings to clearly identify and assess quality issues to determine their significance, category, and impact.
- Guided Root Cause Analysis (RCA) investigation teams identify the root causes of SQE issues and develop appropriate and effective corrective and preventive actions (CAPAs) to address the identified root causes.
- Facilitated RCA investigation meetings, and documented meeting outcomes in meeting minutes, summary reports, or other deliverables.
- Ensured CAPAs were progressed to completion in accordance with the CAPA plan, and implemented within required timelines.
- Reviewed the effectiveness of CAPAs after implementation.
- Facilitated clinical development third-party alliance partner meetings with contracted clinical research organization (CRO) representatives for oversight purposes.
- Mentored clinical development staff in GCP compliance principles.
Senior Program Director, Quality Assurance
American College of Radiology (ACR) Clinical Research Center
Philadelphia, PA
05.2008 - 03.2015
- Designed, implemented, and oversaw the organization's Quality Management System (QMS) to standardize quality management across both grant-funded and commercially sponsored clinical research projects.
- Enhanced clinical trial compliance through development of global policies, procedures, and training programs.
- Led quality planning initiatives for ACR departments under Quality Management Program.
- Supported various departments in establishing KPIs.
- Managed ACR audit program encompassing internal audits, vendor audits, and external sponsor audits.
- Implemented and oversaw procedures to manage quality issues.
- Conducted root cause analysis investigations for quality issues.
- Managed CAPA responses to issue investigations, audits, and regulatory inspections. Supervised the timely development and execution of corrective and preventive action (CAPA) plans.
- Ensured precise staff training allocations through administration of the ACR Clinical Trial Training Program.
- Created tailored GCP training curriculum for ACR Clinical Trial Training Program. Provided annual GCP training with updated content, which featured updates to clinical research regulatory changes.
- Developed and implemented comprehensive procedural documentation and templates for the management of ACR clinical research documents, which included policies, SOPs, work instructions, project-specific guidelines, and training documentation.
- Led the implementation and administration of the ACR document management system (DMS) and the ACR e-learning management system (LMS).
Global Clinical Systems Quality and Data Operations Compliance Manager
Kelly Services, Client: Wyeth Research
Collegeville, PA
10.2005 - 05.2008
- Evaluated Global Clinical Database systems for compliance with FDA 21 CFR Part 11.
- Assessed GCD software validation plans and summary reports for compliance.
- Investigated clinical systems compliance issues, and developed corrective and preventive action (CAPA) plans to address the root cause of issues identified during internal audits or regulatory inspections.
- Supervised development and execution of CAPAs to ensure sustainable compliance.
- Assessed CDM SOPs and work instructions for regulatory compliance with ICH GCP, and offered strategic recommendations for updates.
- Reviewed training materials to ensure consistency with SOPs and work instructions. Worked with the CDM training sub-department to develop and implement the needed changes.
- Evaluated training documentation and records for compliance with current CDM job role qualifications.
- Developed standardized procedures for CDM operations.
- Coordinated with CDM management, internal auditing, and computer systems teams to prepare for regulatory inspections.
Project Lead/ Senior Computer Systems Validation Coordinator
Accenture (through an outsourcing agreement with Wyeth Research)
Collegeville, PA
04.2002 - 10.2005
- Supervised project timelines and deliverables and ensured compliance with 21 CFR Part 11 standards in CDM software projects.
- Developed and analyzed business requirements for GCP-driven software initiatives.
- Oversaw software validation processes and change management procedures, which included creating and reviewing software validation plans, test scripts, validation summary reports, and related SOPs, and work instructions.
- Provided training and mentorship to CDM end users on validation principles.
- Coordinated validation tasks were performed by CDM end users participating in user acceptance testing (UAT) activities.
- Completed software validation tasks including writing, executing, and resolving test scripts.
- Coordinated inspection readiness activities through collaboration with CDM system experts and stakeholders.
- Represented CDM during regulatory inspections of CDM computer systems.
- Oversaw CDM end-user system account access.
Advanced Systems Analyst
Siemens Medical Solutions Health Services Corporation
Malvern, PA
11.1999 - 03.2002
- Conducted a detailed analysis to validate end-user patient management and clinical application business requirements for the purpose of developing the company's first web-based hospital patient management software product.
- Developed business requirements for patient management and clinical applications using Object-Oriented Analysis and Design (OOA/OOD), and utilizing Unified Modeling Language (UML) tools to document requirements.
- Conducted walkthroughs to evaluate patient management and clinical software application design deliverables.
- Developed comprehensive quality assurance test plans for new patient management and clinical applications.
- Performed execution of automated test scripts through Mercury Test Director.
Senior Clinical Data Management Coordinator
Covance Periapproval Services, Incorporated
Radnor, PA
03.1999 - 11.1999
- Directed Data Management team overseeing oncology study data.
- Managed projects and conducted validation of clinical data during drug development.
- Developed data management plans for managing data in accordance with trial protocols.
- Designed tailored report specifications for programmers to develop trial-specific standard reports.
- Executed database setup and validated computer system configurations for drug development projects.
- Ensured the accuracy of clinical data on Case Report Forms (CRFs) from investigational sites, utilizing manual and automated tools, and following SOPs and technical standards.
Project Coordinator
Temple University Health System - Corporate
Philadelphia, PA
06.1997 - 03.1999
- Planned and managed projects for designing, customizing, and implementing Siemens Medical Solutions (SMS) Invision applications.
- Oversaw project schedules, allocated resources, and coordinated team assignments for deliverable completion.
- Conducted requirements gathering sessions for clinical system development projects.
- Tailored clinical applications to meet user requirements using Siemens Medical Systems software.
- Performed quality assurance testing of clinical software applications.
- Conducted user training sessions, and delivered ongoing system support.
Clinical Systems Analyst
Temple University Health System - Episcopal Hospital
Philadelphia, PA
07.1995 - 06.1997
- Oversaw project schedules, allocated resources, and coordinated team assignments for deliverable completion.
- Conducted requirements gathering sessions for clinical system development projects.
- Tailored clinical applications to meet user requirements using Siemens Medical Systems software.
- Performed quality assurance testing of clinical software applications.
- Conducted user training sessions, and delivered ongoing system support.
Education
M.B.A. - Concentration in International Business
Rosemont College
Rosemont, PAB.S. - Health Policy and Administration
Pennsylvania State University
University Park, PASkills
- Quality management
- Quality by Design
- Risk-based quality management (RBQM)
- Risk management
- Root cause analysis
- Audit management
- Continuous improvement
- Clinical Trial Compliance Oversight
- Data integrity
- Inspection readiness
- Strategic planning
- Effective communication
- KPI Development and Analysis
- Organizational Influence
- Team leadership
- Policy implementation
- Analytical thinking
- Contract and vendor management
- Crisis management
- Issue Management
- Cross-Functional Alliances
- Strategic Planning
- Problem-solving
- Decision-making
- Pharmaceutical industry knowledge
- Clinical Research Development
- Verbal and written communication
- Standard Operating Procedure Creation
- Training
- Good Clinical Practice (GCP) Compliance
- Data Management
- Computer Systems Validation
- 21 CFR Part 11 Compliance
Certification
Leadership Professional in Ethics and Compliance (LPEC), 09/19
References
Provided upon request
Civic
Advocate for children and young adults with special needs - (since 2006)
References
References available upon request.
Timeline
Senior Director, Quality and Risk Management (QRM) - Oncology
GlaxoSmithKline (GSK)
11.2016 - Current
Good Clinical Practice (GCP) Compliance Senior Manager
Pfizer
09.2015 - 10.2016
Senior Program Director, Quality Assurance
American College of Radiology (ACR) Clinical Research Center
05.2008 - 03.2015
Global Clinical Systems Quality and Data Operations Compliance Manager
Kelly Services, Client: Wyeth Research
10.2005 - 05.2008
Project Lead/ Senior Computer Systems Validation Coordinator
Accenture (through an outsourcing agreement with Wyeth Research)
04.2002 - 10.2005
Advanced Systems Analyst
Siemens Medical Solutions Health Services Corporation
11.1999 - 03.2002
Senior Clinical Data Management Coordinator
Covance Periapproval Services, Incorporated
03.1999 - 11.1999
Project Coordinator
Temple University Health System - Corporate
06.1997 - 03.1999
Clinical Systems Analyst
Temple University Health System - Episcopal Hospital
07.1995 - 06.1997
M.B.A. - Concentration in International Business
Rosemont College
B.S. - Health Policy and Administration
Pennsylvania State University
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