LIANNE M. CARTT (***) *** - ****

**** ******* *****, ***** ****, Ohio 43123 advjcx@r.postjobfree.com

SUMMARY: Results oriented, process efficiency and compliance focused Computer System Validation Leader and Certified Project Manager, Domestic and International cGMP Compliance Auditor with over 30 years of experience in Pharmaceuticals, Medical Device and the Healthcare Industries. Demonstrated excellence in development, implementation and management of Quality Systems for compliance risk reduction and cost savings. Expert working knowledge in 21CFR 210, 211, 212, 205, 820, Part 11, DSCSA, Data Integrity Guidance and GAMP5.

PROFESSIONAL EXPERIENCE

2007 to Present Cardinal Health Inc., Dublin Ohio

MANAGER, Information Technology, Computer System Validation Engineering January 2019 - Present

Responsible for managing the Corporate Processes used for Computer System Validation Engineering. Manage a team of Software Engineers to execute CSV for Enterprise (Corporate, Pharmaceutical and Medical Segment) Software applications, including a Global Supply Chain platform (S4/Hana), eQMS’s (Smartsolve, Veeva and Master Control, Intellex etc.), Warehouse Management (ERP), Labeling, Validation Life Cycle Management tools (Valgenesis) and Laboratory applications. Responsible for maintenance of the validated state for ~81 validated applications. Lead the organization in CSV Governance to ensure compliant and efficient methods and strategies for software validation.

Responsible to defend CSV documentation during Regulatory, Client and Corporate audits, including FDA, EMEA, Japan, Canadian Health Authority, MDSAP, and BSI audits. Responsible to host IT focused audits as requested by Business and Clients. Defended Cardinal Validation Methodology and execution during ~130 regulatory audits in FY21 with NO Major or Critical findings; on track for ~140 in FY22 with NO observations. Expert working knowledge in 21CFR 210, 211, 212, 205, 820, Part 11, DSCSA, Data Integrity Guidance and GAMP5.

Maintain the Quality System documents used for execution of CSV. Led the redesign of the qualified Sharepoint repository site for distribution of controlled documents. Led the creation of a Web Based Training program and created Role Based Curricula for CSV participants Corporate wide.

MANAGER, Information Technology Quality Assurance, Enterprise Services, Compliance May 2013

Responsible for development, implementation, application, and maintenance of the EIT Quality Management System in support of Computer Systems Validation. Quality Systems include Change Control and Periodic Review for Validated systems and controlled documents, Supplier Management, Internal Audit/Self Assessments, CAPA, Document Management, Training, Solution Delivery Life Cycle Management, and Installation/Operational Qualification of Hardware and Software.

Establish, monitor, communicate and report Key Performance Metrics for Operational Effectiveness of the Quality System and Computer System Validation projects. Identify and implement opportunities for improvements for efficiency and/or reduction of compliance risk.

Responsible for direction, performance management, coaching, career development for 6 Professional level employees as well as creation of succession plans and career roadmaps for each job role.

Manage project intake for validated systems including initial GxP and 21CFR Part 11 risk assessments, determine, review and approve approach for validation based on GAMP5® standards, project estimates and schedules. Ensure adequate qualified resource support is available to meet customer requirements and well as meet internal utilization requirements.

ENGINEER, Enterprise Information Technology, Enterprise Services, Compliance 2011- 2013

Develop, implement and manage the Document Management and Training system in compliance with FDA regulations. Manage the development, approval, distribution, training, periodic review, retention and destruction for 138 Quality Systems procedures and any related documents which require control. Established metrics and monitor the Document approval process to ensure timely implementation of controlled documents. Manage projected labor resource requirements to ensure timely periodic review and development of new procedures for the Quality System in EIT. Identified the need to ensure employees receive annual GMP training. Led the development and implementation of training for all

Lianne Cartt – Page 2

EIT on the expectations, repercussions, benefits, management and personal responsibility the FDA maintains for those involved with regulated systems.

Act as Manager of the Quality Services team in EIT ES Compliance. Responsible for performance management of employees, including career development, coaching, and evaluation. Provided cross training of employees to ensure business continuity and knowledge growth. Led effort for Compliance and was the first group in EIT to create the Career Roadmap for P1-P5 positions.

Responsible for the management, including issuance, tracking and review of Installation and Operational Qualification documents as part of Computer Systems Validation. Led effort to revise the IOQ process to improve cycle time of documents as well as completion of documents correctly. Created, socialized and gained management agreement to establish goals and communicate via Dashboard. This enabled the team to close 156 overdue IOQ documents within 3 months and reduced cycle time by 44.4 days. Established the process to control the cycle time of IOQ documents and through continuous monitoring, communication and escalation have accomplished 12 consecutive months of no over-due documents. As part of continuous improvement, challenge current methodologies and concepts to identify opportunities for process refinement and address pain points for customers by acting as a liaison between the Computer System Validation team and customers.

Managed an IOQ Inventory Project which resulted in the review of 2942 documents, both hard and soft copies, scanning 1609 documents and destruction of 330 documents no longer required for retention. The project was completed within budget and 2 months ahead of schedule.

Project Manager for the harmonization of Cardinal Health Change Control processes for Validated Computer Systems. This project will enable risk reduction through a consistent and compliant approach to current FDA and industry expectations.

PROJECT MANAGER – Enterprise Information Technology, Shared Services, Compliance 2007-2011

Develop, train and implement a Corrective and Preventative Action (CAPA) Process for Enterprise Information Technology (EIT).

- Develop project plan from concept through solution delivery of a CAPA process. Facilitated concept creation, development of a global risk scale, issue/root cause categories, User Requirement Specification document and project funding..

- Led team to combine EIT teams managing Information Security, FDA, Corporate IT Audit and SOX issues to utilize one tool for management of information, via Sharepoint®. Create Job Aide and train users on Risk customized Sharepoint® site.

Developed a global EIT CAPA procedure and facilitated procedural development of aligned in-scope Administrators.

Educated/Consulted EIT on FDA requirements on Quality System expectations, including validation. - Develop Document Management process and procedure for EIT

1998 to 2007 Boehringer Ingelheim Roxane, Inc., Columbus, Ohio

PROJECT MANAGER & REGULATORY COMPLIANCE AUDITOR 2004 – 2007

Facilitated site wide Quality System improvement initiatives which led to compliance risk reduction to zero from an assigned value of 8 (on a scale of 0-10, with 10 being Facility Closure and 0 being no risk).

Led team to develop a validated process to collect Quality Systems data, via TrackWise®, to consolidate into a site wide Corrective And Preventative Action Tracking System. This resulted in timely close out of CAPAs and the identification of global CAPAs which reduced compliance risks in Operations and Quality.

Facilitated cross functional team to map the process, develop and validate an Electronic Forms system which resulted in a reduction of Manufacturing/Packaging deviation investigations and documentation errors by 50%.

Devised strategy, project plan and led team to reduce Foreign Material in Quality Control Sampling and Solids Manufacturing by 67% and a cost reduction of $34,000.

Led teams to audit and remediate/validate the top 10 identified Equipment Systems within the site. This resulted in a successful review by the FDA, and other regulatory authorities without any deviations or adverse comments.

Lianne Cartt – Page 3

Gathered and evaluated metrics associated with Compliance initiatives (including resource requirements, budget and materials), consolidated and resolved existing issues, initiated and managed closure of projects and sub-project activities within given time frame to facilitate initiatives.

Individually conducted and led teams to audit internally and suppliers, both domestic and international for compliance with cGMP of Active Pharmaceutical Ingredients, liquids and solids oral dosage pharmaceutical forms and packaging component vendors to maintain good regulatory standing and reduce compliance risk.

Performed detailed audits with FDA, EU, EMEA, Q7A and Corporate EHS/cGMP guideline expectations which led to harmonization of interpretation and global expectations for compliance within the Boehringer Ingelheim Sites.

AUDITOR III, REGULATORY COMPLIANCE 2001 – 2004

Led and Managed FDA Device and Drug Inspections: Performed preparation, led and accompanied Supplier, FDA and International Governmental Agents during PAI and cGMP inspections.

Led cross functional audit teams and conducted Vendor/Supplier API, Product, Packaging Component and Labeling Audits which led to the identification and re-contracting of a high risk supplier.

Maintained responsibility for internal compliance of production Operations, including Solids, Liquids and Aseptic filling Manufacturing and Packaging processes, which led to stabilization of the facility regulatory standing with the FDA.

Led cross functional site teams, to improve Quality Systems which resulted in the development and implementation of a site wide tracking system for defective material and components. This enabled accurate feedback for suppliers and to Quality for prioritization of supplier audits.

Develop, write and train the Boehringer Ingelheim Roxane Inc. site on Standard Operating Procedures to increase compliance and reduce deviation investigations.

UNIT LEADER, SOLIDS PACKAGING 2000 – 2001

Actively provided strong leadership, performance and process management and production floor support to optimize resources for 31 non-exempt employees on second and third shifts.

Developed and utilized effective teaching, coaching, counseling, and disciplinary skills to support and foster strong and effective interpersonal relationships and team performance. Led shift and departmental meetings to ensure adequate communications between and during all shifts in Solids Packaging

Effectively identified and coordinated resources to develop interdepartmental support and service and facilitated continuous improvement activities. Provided resources and drove for process improvements.

Supported the development, documentation and communication of recognized metrics to monitor business unit performance.

Ensured that departmental activities are conducted in compliance with cGMP, FDA, DEA, OSHA and other applicable regulatory and company guidelines.

AUDITOR I, REGULATORY COMPLIANCE 1998 – 2000

Conducted supplier and internal cGMP compliance audits. Assisted with facility audits, including interaction with FDA Inspectors.

Conducted discrepancy and customer complaint investigations and write detailed reports, summarizing findings and provide recommendations for lot disposition. Tracked the completion of corrective actions committed to by production and support departments as determined during investigations.

Provided production management with discrepancy trend reports utilizing Access database. Work with production to identify root causes and to reduce significant trends.

Worked with production management to facilitate process improvements and compliance within cGMP guidelines

Wrote, revised and/or coordinated cGMP Standard Operating Procedures and provided site training on revisions

1990 to 1997 Abbott Laboratories – Ross Products Division, Columbus, Ohio

ASSISTANT MICROBIOLOGIST

Conducted methods validation and routine analysis of Abbott Laboratories and competitor nutritional products and commodities for Vitamins B12, Biotin and Pantothenic Acid via microbiological bioassays.

Lianne Cartt – Page 4

Trained personnel to conduct bioassays, interpolate, statistically interpret and report data, use SAS, Lotus 123 and Lotus Notes based software programs to provide customers and management with sample tracking capability and current laboratory productivity statistics

Conducted methods development for non-destructive spoilage determination on containers, microbial Bioburden on devices and spoilage characterization on new products and containers.

Isolated and identified possible microbiological pathogens found via sterility testing in Abbott Laboratories and competitor nutritional/consumer products.

Provided microbiological support for validation of new production aseptic filling lines.

EDUCATION

The Ohio State University, Columbus, Ohio

Bachelor of Science in Microbiology with Minor in Chemistry

ADDITIONAL TRAINING

ISPE Basic Principles of Computerized Systems Compliance using GAMP5®, including revised Annex 11 and Part 11 Update (May 2013)

Project Manager Certification, Xavier Consulting Group, Management Development Program, Fisher Business College, The Ohio State University (2007)

Audit Training: Jeff Yuen and Associates, Janet Burke QC Laboratory Auditing, Annual FDA and Current Challenges of GMPs, CAPA seminars

Computer Systems: Microsoft Project, Access, Word, Mind Manager, Excel, Trackwise

Low Acid Food School: conducted by The Ohio State University (1996)

EHS Training: Incident Fire Brigade Leader (1997-2001)

Emergency Medical Technician – Paramedic Certification

Contact this candidate