Data Integrity Computer System

JASMINE RETUTA

PROFILE

Computer System Validation

and Data Integrity Assessment

professional with 30 years’

experience in the evaluation,

configuration implementation,

and validation of enterprise

wide, GxP process related

pharmaceutical computer

systems as a Business Owner,

System Owner, Quality

Assurance, Quality Control

and/or Computer System

Validation capacity. An expert

in validation techniques for

the implementation of LIMS,

Building Management

Systems, Chromatography

Data Systems, Electronic Data

Management Systems,

Manufacturing and

Laboratory Automated

equipment and Infrastructure

Systems.

EDUCATION

St. Peter’s College

1991 - 1996

Bachelor of Science in Chemistry

WORK EXPERIENCE

CARsgen Therapeutics, QA Manager, Computer System

Validation (CSV) and Data Integrity (DI)

April 2024 – present

• Manage all aspects of the computer system validation program.

• Develop, maintain, comply, and support CSV policies and procedures.

• Implement and meet global requirements while ensuring the highest level of compliance with regulatory agencies. Track changes to the regulatory environment and implement processes and procedures enabling CARsgen to meet ongoing requirements such as 21 CFR Part 11, EU Annex 11, and MHRA data integrity guidelines. Independently manage projects and make sound decisions related to product quality issues.

• Ensure compliance and update as required the CARsgen Validation Master Plan for all computer systems. Maintain compliance and enhance computerized system validation (CSV), policies, standards, processes, SOPs and other documents, and provide guidance and counsel as needed. Key player in the development, implementation, and maintenance of cGMP quality operational processes for the manufacturing of cell therapies.

• Manage the execution and documentation of the CSV Program. This includes all CSV activities, documentation requirements, and reports including plans, risk assessments, function requirements, periodic reviews, configuration specifications, testing, change controls, traceability matrix, qualification protocols, validation, and compliance reviews.

• Serve as the CSV SME during audits and for any standards.

• Develop a culture of data integrity excellence by ensuring appropriate systems and processes are in place to support GMP data integrity. Ensured equipment meets requirements for data integrity security.

• Subject Matter Expert for all data integrity inquiries, monitor and maintain the site data integrity plan reporting to site leadership and senior management.

• Setup and maintain a site network team of functional Data Integrity SMEs within GMP functional areas of Manufacturing, Maintenance, Manufacturing Science and Technology (MS&T), Engineering, and Quality Assurance Operations.

• Develop and implement data control strategy for manufacturing and laboratory equipment.

• Ensure site support for investigations, rapid alerts, reviews, and audits focused on internal and external DI.

Kite Pharmaceuticals, Sr. Quality Engineer II and Corporate Data Integrity Lead

September 2022 – February 2024

• Leads efforts/teams focused on identifying primary root causes and implements corrective and preventative actions to ensure minimal errors/issues.

• Develops and implements processes, documents, and systems in conjunction with other team members.

• Develops and implements systems by identifying critical process steps which could culminate in possible sources of manufacturing defects. Devises methods to reduce process variation to reduce/eliminate the cause of defects.

• Creates training materials by applying body of

knowledge/expertise and communicating to respective team.

• Provides project management and sustaining engineering leadership for contract manufactured products.

• Leads cross-functional teams, including quality assurance, manufacturing operations, suppliers, and internal customers.

• Drives and demonstrates compliance with agency

regulations/guidance and standard operating procedures regarding process validation and risk management.

• Authors technical investigation reports, including root cause.

• Supports quality system requirements via the change control process, and fields complaint investigations.

• Performed data process mapping to assess inflection risk areas in a computerized system.

Bristol-Myers Squibb, Sr. Manager GxP IT Auditor

March 2022 – August 2022

• Provide quality assurance oversight across the end-to-end product lifecycle for software development and validation lifecycle activities associated with regulated computerized systems to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and BMS requirements.

• Carries out functions of the Global Quality GxP ITQA Quality and eCompliance tower as directed including but not limited to:

• Review and approval of key computer system validation lifecycle

(VLC)

• Oversight of key software development lifecycle (SDLC) processes such as problem, incident, change, release, deviations, etc.

• QA Review and approval of validation deliverables associated with various BMS systems such as clinical study databases, electronic Case Report Forms (eCRF), and Interactive Response Technologies (IRT), enterprise commercial manufacturing systems such as electronic laboratory notebooks and manufacturing execution systems, local laboratory systems.

• Ensure adequate and timely quality assurance/regulatory support.

• Report on key metrics across the tower

• Provide support during regulatory agency and 3rd party inspections.

• Research new technologies, understanding existing processes and reference recognized standards and frameworks.

PharmEng Technology, Sr. Manager of Computer System Validation

November2021–March 2022

• Drive overall quality performance and compliance throughout the global organization by defining, implementing, and maintaining the CSV program.

• Build CSV project schedules, track deliverables, update stakeholders and ensure projects stay within budget.

• Review existing CSV reports and regulatory compliance.

• Develop strategies and plans to close the gaps in an efficient and technical manner.

• Develop and communicate expectations for quality performance, continuous improvement, quality systems, process controls infrastructure for critical sustaining parts and new products.

• Monitor and drive corrective action and continuous improvement activities that directly impact performance measures.

• Provide day-to-day support to development, engineering and manufacturing for design control planning and design transfer activities.

• Work with end users and process owners to collect data to support protocol requirements, analyze data collected and create CSV reports.

• Coordinate with end users and process owners to resolve any identified issues to bring validation to acceptable levels.

• Coordinate with end users and process owners to lead development of CSV protocols.

• Participate in project management meetings as Validation representative determining CSV requirements as needed.

• Learn and understand the applicable technology and engage in technical discussions.

• Identify areas and opportunities to improve CSV in facilities, processes, and equipment.

• Provide consultation to other departments performing CSV activities.

• Ensure validation program meets requirements of FDA (21 CFR Part 11) and ISO

Ziopharm Oncology, Sr. Manager of Computer System

Validation

January2021–October 2021

• Work with relevant departments to setup an equipment management program for the lab and GMP manufacturing facility, including but not limited to, equipment validation, calibration, maintenance, and tracking systems.

• Determine SOPs required and participate in the authoring and/or review of SOPs to support the Equipment Management Program developed.

• Provide computer system validation support for computer system assessments, validation and change control, and provide effective Quality support at all applicable points of the Computerized System Life cycle (CSLC)

• Provide expertise in assessing the overall IT program and work with stakeholders to ensure the systems, SOPs and overall documentation is sufficient for phase appropriate activities and internal requirements.

• Perform timely and effective QA review of validation documentation such as Validation Plans, Traceability Matrices, testing deliverables, SOPs, and data migration plans.

• Provide timely updates on IT Validation projects and deliverables to Quality Management Systems.

bluebirdbio, Sr. Manager of Computer System Validation August2019–December 2020

• Responsible for providing oversight, review and approval of GXP deliverables and applicable Computer Systems validation initiatives including specifications and requirements, policy and procedural documentation, validation documentation, and change requests. Function as IT technical lead for evaluation of validation/qualification approach.

• Partner with:

o Business and System owners in overseeing GxP system assessments, participating on cross-functional teams through the system development lifecycle.

o QA in executing, supporting vendor and contactor audits.

• IT compliance and Quality teams to further develop Computer Systems Compliance governance processes.

• IT Compliance and Quality to monitor observations and issues identified during audits. Report progress, and justify or remediate the issues identified, initiating CAPA, performing gap analysis, and implementing process improvements where required.

• Provide:

o Technical leadership and support to the bluebird bio IT organization by; assessing and make recommendations on computer-related systems, databases and tools to be used in execution of Enterprise systems.

o Technical support as the Computer Systems Compliance SME during the development of system documentation such as user requirements, procedures, training modules, etc. o Oversight to content and documents developed by vendors or consultants and maintain policies and procedures along with draft validation documentation (e.g., VMP’s, UAT’s, Gap Protocols, etc.)

Mavens, Director of Quality

February 2019 – August 2019

• Responsible for the creation of Quality Management System at Mavens and formalizing the process and procedures over four key elements of the Quality Management System at Mavens: training, document management, validation/testing, and auditing. Responsible for the validation testing and creation of document deliverables for validation process for Mavens MIC product.

Edgewell Personal Care, Sr. Manager of Computer System Validation

November 2018 – January 2019

• Responsible for the development planning and execution of risk based Computer System Validation (CSV) to ensure compliance with regulatory requirements for the lifecycle of

validated/qualified optimization of the CSV lifecycle program and manage audits of current/prospective suppliers of software applications and services.

Regeneron Pharmaceuticals, Manager QA Validation

October 2017 – November 2018

• Lead the qualification of Laboratory equipment and software at Regeneron’s Rensselaer (Commercial Manufacturing) facility.

• Lead assessments and gap analysis regarding data integrity, 21 CFR Part 11 Regulations,

• Participated and defended validation data in regulatory inspections.

Regeneron Pharmaceuticals, Software Project Manager QA Validation

April 2014 – October 2017

• Created the standard operating procedures and templates required for Infrastructure Qualification.

• Originated the qualification efforts for Infrastructure Qualification to ensure that Regeneron was in compliance to Annex 11.

• Created a CSV Task Force to ensure that all GxP systems were validated in a consistent manner.

• Qualified the infrastructure platforms (e.g., Data Center, backup/restore, network) for new site in Ireland.

Regeneron Pharmaceuticals, Project Manager for Quality Assurance and Auditing (QAA) Validation

October 2013– April 2014

• Established and maintained validation process and procedures for computerized systems within the Tarrytown and Basking Ridge areas of Regeneron Pharmaceuticals.

• Liaised with representatives from IT service providers and vendors to ensure that compliance expectations are clear and the approach is efficient.

• Partners with Business Process Owners, Business Functional IT Organizations and System Owners to educate and establish the quality standards required for Computerized System Validation

(CSV).

• Ensured early Quality involvement in Site IT Projects with clearly defined expectations.

Regeneron Pharmaceuticals, Sr. Quality Assurance

Computerized Systems Auditor

July 2012– October 2013

• Scheduled, prepared and conducted computerized system audits in support of GCP, GLP, PV, SUB and/or GMP as directed.

• Responsible for identifying internal and external audit targets. Interpreted policies, standards, and regulations; identified potentially critical problems and/or business risks and communicating all findings to senior level management. Boehringer Ingelheim, Sr. Principal Business Analyst October 2009– July 2012

Representative of the US organization in IS Quality Expert Group in Boheringer Ingelheim which included the following responsibilities:

• Qualification of Infrastructure Related Systems supporting GxP environments. Responsible for developing SAAS/Cloud Computing Assessments/Audits Working Instructions.

• Responsible for Database Qualifications

• Project managed the adoption of corporate SOPs to BI USA regions

• Consult in the qualification of technologies at a data center provisioned for the BI US region.

Valiance Partners, Sr. Validation Engineer

February 2007– October 2009

Responsible for the coordination efforts of validation for centralized enterprise systems at client sites at Johnson and Johnson and Pfizer. At those sites the following activities were performed:

• Creation of validation plans for trial management file systems, electronic data management systems, and IVRS/IXRS related systems

• Creation of IQ, OQ, PQ, Traceability Matrices and summary reports (IQ, OQ and final validation summary reports)

• Creation of SOPs and training materials for System Administrative and Operation of systems validated

Genzyme, Validation Engineer III

2004– February 2007

• Responsible for the validation efforts regarding LIMS, Business intelligence systems (ERP, MRP) and Building Management Systems.

• Responsible for the qualification of a capital project that moved the infrastructure data center for Genzyme from one facility to a remote Infrastructure as a Service facility.

Amgen Colorado, Validation Engineer II

2001–2004

• Supervised 6 consultants in a 21 CFR Part 11 Initiative taken on by the QC team in Colorado.

• Created validation strategies for the validation of all laboratory equipment.

• Executed IQ, OQ, and PQ testing.

• Created Validation Plans, Summary Reports, IQ, OQ, PQ and SOPs

• Created and executed training on typical validation procedures and the use of GAMP.

• Reviewed and signed Validation Plans, IQ, OQ, PQ, SOPs and summary reports (validation as well as testing)

Rosemont Pharmaceuticals (Denver)/Upsher Smith, Validation Scientist II

2000–2001

• Created Computer System Validation policies

• Performed and Created scripts for Validation of solid dose manufacturing systems (Gruenberg Oven, Blenders, mixers, tablet press, etc)

• Created and Performed Validation of BMS system and Alarms system.

• Responsible for Audits in the manufacturing area

• Performed validation on process (packaging and manufacturing)

• Created a cleaning specification for cleaning validations for equipment.

• Performed smoke tests for manufacturing room qualifications. Pharmcomm (Cetan Technologies), Computer Validation Scientist

1998–2000

• Performed computer system validation on chromatography data systems (Turbochrom, Millenium, and Total Chrom)

• Created IQ, OQ, PQ testing and executed aforementioned testing

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