Senior GMP/GCP/GLP Consultant

Experience:

Project 17: Co-lead deviation backlog reduction project

• Assist the client in the deviation backlog reduction project by performing remote investigations.  Main focus was conducting manufacturing investigations and CAPAs related to their automated processes.  Recommendations for process improvements related to operations and the quality management system.

Project 16: Warehouse Audit

• Perform a warehouse facility audit for IPEC, SQF, Good Distribution Practices, applicable sections of 21 CFR §210-211 and Part 11. The warehouse inspection identified areas of conformance and non-conformance with FDA regulations including observations and deficiencies and risk-based corrective action plan so client could determine suitability and any changes necessary to be in compliance. 

Project 15: Software Audit 

• Conduct a vendor software audit for externally hosted track and trace software per 21 CFR Part 11 and accepted industry practices.  Review vendor validation practices and documentation against internal SDLC and industry expectations.
• Assess the quality management, management responsibility, resource management, production realization and measurement analysis and improvement systems for compliance to 21CFR Part 11, Annex 11, MHRA GXP Data Integrity Guidance and Definitions, PICS DRAFT Good Practices for Data Management and Integrity, EMA Q&A Data Integrity, WHO Guidance on Good Data and Record Management and FDA Data Integrity and Compliance with CGMP.

Project 14: CSV Assessment (internal) for Maintenance & calibration software

• Conduct a computer software validation assessment for internally hosted maintenance and calibration software per 21 CFR Part 11 and accepted industry practices.
• Ensure executed validation documents adhere to established procedures and industry expectations
• Assess the compliance of the internal software used by the client and identify areas of conformance and non-conformance with FDA regulations, including observations and deficiencies and risk-based corrective action plan.

Project 13: Design & Implement a sustainable Data Integrity Governance and CSV program

• Assess prior audit findings and conduct supplementary data integrity audits of GMP systems and equipment for short and long term remediations.
• Assess all GMP and related SOPs & processes for embodiment of data integrity principles and classify & identify gaps for remediation.
• Assess organizational readiness for weaknesses and gaps to support the data integrity program. 
• Conduct computer system validation reviews of quality, laboratory and manufacturing systems for compliance to regulations and assessment to ensure testing aligns with the processes in-use. 
• Review manufacturing processes (paper & electronic) for data integrity and recommend remediations.
• Design a process for data integrity controls on instruments and equipment.
• Conduct process flow and data mapping workshops.

Project 12: Data Review, Data Integrity & Computer Validation Audit & FDA 483 response (China)

• Conduct data review of chromatography systems (Agilent/Empower). Ensure that all data was reported accurately & confirm product impact.  Analysis of audit trails, sample injection data and system error messages for compliance issues. 
• Conduct computer system validation reviews of quality, laboratory and manufacturing systems for compliance to regulations and assessment to ensure testing aligns with the processes in-use. 
• Review the Investigations related to data integrity.
• Conduct site-wide audit of quality processes for adherence to regulations and established procedures.

Project 11: Data Integrity Acceleration Project, Lead consultant for GxP Data Integrity assessments (Global)

• Conduct data integrity (DI) assessments for global manufacturing sites which include both pharmaceutical and medical devices.  The assessments include all areas with potential impacts for data integrity across the organization. 
• Conduct a data integrity assessment of global supply organization and suppliers.
• Assist with the creation of internal global remediation team.
• Conduct DI related data reviews and “actual vs reported” data.
• Create a corrective action plan based on audit and gap assessment findings
• Consult and advise on global Segregation of Duties (SOD) for SAP project.
• Consult and advise on global electronic batch record (EBR) project.
• Consult and advise on local DI related investigations, deviations, change control and remediation plans

Project 10: Compliance Enhancement Project, CSV Team Lead for GMP System Validation (CSV) and Quality System (Taiwan)

• Create a corrective action plan based on audit and gap assessment findings
• Conduct data quality reviews of laboratory systems. (Actual vs reported), audit trail reviews.
• Compliance review of investigations, deviations, change control, CSV 
• Create validation plans for multiple GxP systems.
• Identify staffing requirements, training needs and train the IT and GMP staff.
• Create a computer system quality management system and IT framework to comply with agency GMP/GLP requirements for 21 CFR Part 11, Annex 11, HC, Japan, Taiwan.
• Introduce and train on basic service management concepts.
• Provide expert design and oversight for construction of a compliant corporate data center and Infrastructure qualification
• Write and review policies and SOP’s for computer system validation, data integrity and operations
• Writing, review and execution of protocols and qualifications for GMP software systems which included laboratory (LIMS), manufacturing (PLC), regulatory, SAAS (cloud) and ERP systems and computer system validation and retirements.
• Provided project management for validation projects

Project 9: Data Integrity & GMP Computer System Validation audit (China)

• Audit CSV qualifications (LIMS, PLC, Empower) for compliance to regulations
• Audit computer system SOP’s and procedures for GMP/GLP compliance
• Reviews computer systems for data integrity issues (LIMS, PLC, Empower)
• Review computer system quality system framework and validation approach 
• Compliance review of investigations, deviations, change control 
• Prepare an audit report and perform a gap assessment of findings

Project 8: Mock FDA Computer System Validation & SAAS Cloud based infrastructure audit (US)

• Reviewed clients’ qualification and application CSV validation approach and documentation for an SAAS (cloud) application and review of SAA vendor compliance to 21 CFR Part 11 requirements.
• Provided expert guidance on corporate SOP’s CSV and 21CFR part 11 compliance frameworks.

• Conducted expert review of, SOPs, data integrity and qualification protocols/reports.   

Project 7: Senior CSV consultant for compliance enhancement program, which included review and creation of CSV related SOP’s at the site 

• Provided expert guidance on corporate CSV and 21CFR part 11 compliance frameworks
• Reviewed and provided guidance on IT SOPs and assessment of CSV system life cycle, master validation plan and the site IT operations and administration procedures.
• Provided expert guidance for local retrospective Infrastructure Qualification protocols/SOPs and reviewed executed qualifications.   
• Performed IT computer system validation and 21CFR Part 11 assessments for Trackwise, LIMS, ERP and various stand-alone laboratory systems. 
• Compliance review of investigations, deviations, change control 

Project 6: Senior verifier for CSV Warning Letter/Audit observations, provided system validation reviews, Advisor/mentor/reviewer for corporate & local IT guidelines/SOPs and Infrastructure Qualification assessments (India)

• Senior verifier/advisor for all CSV observations at the site, periodic review of gaps with corporate and local management.
• Provided expert guidance for corporate wide retrospective/prospective Infrastructure Qualification protocols/SOPs at all sites and corporate headquarters.  
• Performed IT computer system validation and 21CFR Part 11 and annex 11 assessments for Trackwise, LIMS, ERP and various stand-alone laboratory systems and verifier for executed qualifications.   
• Provided guidance on regulatory requirements of corporate/local IT guidelines, SOPs and assessment of CSV system life cycle, master validation plan and the IT control framework.

Project 5: Compliance Enhancement Project: Project manager & oversight for Quality Audits of 64 drug products, 15 Quality Systems, conducted 21CFR Part 11 assessments and IS validation reviews

• Developed project plan and audit plan for all audits.  As project lead, responsible for; project oversight of 3rd party oversight consultants for interim controls, Quality System Elements assessments and product quality auditors.  Devised and reported metrics for third party document review and initial review of all quality system audit reports.
• Performed CSV Quality System GMP audits and 21CFR Part 11 and annex 11 assessment, review of SOPs, master validation plan, identified areas of improvement to address recurring problems and created the audit report.  Systems; SCADA, Laboratory systems, vision systems, recipe management, BMS, general IT systems, print management, training, CAPA, Complaints.
• Compliance review of investigations, deviations, change control, labeling systems 
• Performed 3^rd party GMP/GLP review (Interim Controls) of computer system validation documents, protocols, and qualifications
• Performed joint GMP audit reviews for 15 Quality systems
• Advisor to the Sustainable Compliance team on strategy and Interim Control business processes

Project 4: Provided oversight and project management for Quality Audits of 35 drug products

• Evaluated procedures and controls at external vendors
• Presented critical findings resulting in enhanced client oversight of external manufacturer 
• Provided executive and technical review of audit reports

Project 3: Lead consultant for packaging component transfers

• Review and audit all relevant policies, SOP’s and agency regulations
• Conduct vendor audit of relevant SOP’s and processes
• Develop packaging component transfer methodology
• Obtain multi-site & multi-company alignment on project approach
• Coordinate multi-site/multi-company project teams
• Author/rewrite SOP’s to reflect changing business model

Project 2: Provided oversight and project management to a team of global auditors to determine risk and reliability of clinical trial data due to an FDA WL related to a sNDA submission.

• Designed database for audit findings and performed data mining of the findings to determine final conclusions
• Created audit protocols, worksheets, standardized questionnaires and tracking metrics
• Presented timelines and audit progress to client during recurring meetings

Project 1: Provided project management and IT review of 15 global clinical quality systems (GCP)

• Evaluated the software applications used for quality systems and qualifications
• Created protocols, worksheets, standardized questionnaires and risk evaluation scale and tracking metrics
• Conducted 21 CFR Part 11 and annex 11 CSV review of 15 clinical business GCP processes
• Performed executive review of audit reports for technical content
• Created process flows for all business processes audited

Becton Dickinson Inc.,                           2000 to 2007

Global IT Project Management Office Leader

Created and led a team of IT project managers.  Responsible for designing and building project management governance processes and functions within global IT, partner with business for portfolio management, project execution, institution of SDLC processes, providing project oversight/governance. Ensure projects adhered to computer validation requirements.

• Provide PM and technical oversight for; GMP/GLP computer systems (LIMS, MES, ERP), SAAS cloud, Anti-spam, Intrusion detection tools, Change Control, Lotus Notes, Clinical Data projects, SAP Enterprise and portal projects, Infrastructure, Oracle, Windows, Virtual Server, Data Center Migration, BCP and DRP projects.
• Partnered with internal auditor to conduct technology site audits for merger & acquisition targets.
• Facilitated risk assessment meetings
• Partner with compliance and IS validation to create global 21CFR Part 11 & annex 11 assessment SOP’s, processes and forms. 
• Project manager and lead technologist for IT merger & acquisition projects, clinical data management and clinical trial management projects.  
• 6 Sigma Green belt training instructor

Global Technical Services Manager

Lead a global team of 25 technologists and provided global technical services to the business, and technical assessments for all global platforms and applications.  

• Demonstrated expertise in leading a best-in-class global IT engineering & operations team

• Authored/Reviewed Service Level Agreements (SLA), Disaster Recovery Plan creation and execution for all enterprise applications and decommissioning SOPs

• Conducted SOX, ISO Guidelines, GMP computer assessments to ensure SAP and security and related GMP systems were compliant

• Designed and Implemented EDM document control and change control systems

• Authored corporate IT computer and infrastructure validation SOP’s and IT QMS framework to comply with 21 CFR Part 11 and annex 11 regulations

• Lead global infrastructure engineering and SAAS cloud review and implementations

• Authored and approved computer validation documents, protocols and qualifications

• Authored and reviewed ITIL Service Management Plan/Build/Run framework and identification of required artifacts disaster recovery and business continuity plans

• Conduct Compliance Self-Assessment reviews of infrastructure and global applications, achieved highest compliance rating in global IT audits

• Implemented global Change Management, Service management, CAPA solutions

• Led SAP Basis, Security engineering, storage engineering, UNIX engineering teams

• Conducted SOX, CAPA, ISO audit and validation assessments, Six Sigma training and certification, ITIL service management and operational effectiveness certification

• Conduct vendor audits and evaluations (data centers, software vendors)

• Completed certifications in 6Sigma green & black belt, ITIL foundation and service management

SAP Basis Manager

Lead a team of 12 SAP Basis Administrators, Unix administrators, Storage Engineers responsible for global SAP architecture, infrastructure, administration, Storage engineering, Disaster Recovery Planning, Business continuity Planning, SAP Landscape design, upgrade methodology.  SAAS Cloud, Managed ERP, SCM, Portal, HR, Warehouse management, data warehouse, document management, established cross departmental capacity planning processes

Price Waterhouse LLC,                                   

Senior SAP Global Architect and consultant providing; management and technology consulting services, global SAP solutions, organizational readiness assessments and infrastructure services. 

Advised on 11 Global US based SAP implementations and provided architecture, security design, implementation guidelines and oversight. 

Project 5: Retail Industry, Technical Architect, SAP Technology Lead

• Perform readiness assessment, organizational assessment and technology audit.  The scope included all datacenters, networks, hardware, software applications and skills assessments base lined to Best Practices.  The findings and recommendations were presented to senior management.

• Project Lead for 45 technology team members for Infrastructure/architecture, network, SAP Security, Development and Basis staff.

• Advise, Engineer and lead the design of the datacenter, network, hardware and software architecture required to support a global SAP implementation.

• Business process re-design team member.

• SAP global rollout, system engineering, performance and tuning, implementation of monitoring system, DRP and BCP plans.

Project 4: Consumer Products, SAP & Storage Architect

• Create SAP technology roadmap and security/basis/infrastructure design to support the global implementation of SAP and presented design to senior management.

Project 3: Consumer Products, SAP Basis & Security

• Perform SAP upgrades, sizing assessments, storage design, workload analysis, Security design and assessments, Oracle migrations, installations and upgrades, UNIX/Windows administration and troubleshooting.

Project 2: Medical Devices, SAP Basis & Security

• Perform SAP upgrades, sizing assessments, storage design, workload analysis, Security and role design, Informix migrations, installations and upgrades, UNIX/Windows administration and troubleshooting.

• Implement change control and document management systems.

• Create SAP technology roadmap and infrastructure design to support the global implementation of SAP and presented design to senior management.

• Evaluate and Review Testing systems, Authored protocols and executions (IQ/OQ/PQ) and change controls for SAP for pharmaceutical company under Consent Decree

•  Authored the qualification, validation and decommissioning documents for; datacenter, hardware and software systems.

Project 1: Pharmaceutical, SAP Basis & Security

• Project lead and technical advisor for data center requirements/design project.

• Perform SAP administration, support global rollout, workload analysis, Security Design, job role harmonization, Oracle migrations, installations and upgrades, UNIX/Windows administration and troubleshooting.

• Implement IT change control board/process/systems.

• Author protocols and executions (IQ/OQ/PQ) and change controls for SAP.

• Technical advisor for global LIMS rollouts and SAP integration

• Authored the qualification, validation and decommissioning documents for; SAP Basis, UNIX administration.

* Additional experience available upon request

Education &Certifications:

Bachelor of Science, Bethany College, Bethany WV, 6Simga Black & Green Belt, ITIL Service Management certification, CISA (underway), Solaris/SUN certifications (Enterprise, Workgroup, Network, System Admin), 6Sigma Green Belt Instructor, PMP (underway), University MS Excel Instructor

Skills Highlights:

Experienced with CSV/IS Audits, 21CFR Part 11 assessments, Data Integrity assessments, Organizational assessments, Process Design, 6Sigma Green/Black belt, Management Consulting, Project management, portfolio management, Computer System Validation (21CFR part 11) and technical writing.

Language/Travel: 

Current Chinese visa

English (native), Spanish (basic), Chinese (introductory), valid passport, able to travel as needed.