Lyn Marsh, ASQ-CQA

Experience

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  Catalytica Pharmaceuticals, Inc.

  Mar 1997 - Dec 2000

  In April 1999, I was hired by Catalytica Pharmaceuticals as a Validation Technician and continued to expand my knowledge and expertise in the area of computer validation and quality. In addition to the duties of the previous position, I was also responsible for identifying areas of non-compliance and potential risk and present those areas to upper management along with potential solutions. I also served as the validation team member on an 18-month implementation of a multiple-site customized electronic document management system. Show less

  • Validation Specialist

    Apr 1999 - Dec 2000

  • Validation Technician (Contractor)

    Mar 1997 - Apr 1999
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  DSM

  Dec 2000 - May 2005

  During this position, I was the Validation Project Manager for SAP R/3 Implementation (including SD, FI, CO, AA, PM, MM, PP-PI, QM, PS, CO-PC, WM & interfaces to GMP systems) that replaced more than 20 existing systems. This project and implementation was approximately two years in length and consisted of meeting local site business needs and integrating those with corporate requirements and system expectations. This system contains a core set of functionality used by all company sites as well as custom functionality used by each site. I remained the lead for the IT validation group and continued to provide and manage timelines and other on-going activities to ensure the business continued to operate while implementing SAP. Show less As a member of the site Information Technology department, I was responsible for the validation of all site computer systems. As a leader within the validation group, I was responsible for setting timelines and ensuring those timelines were met and obstacles were resolved. I continued providing training to the department and site on validation, quality practices, and regulatory requirements. I was the validation lead for multiple implementation projects, many simultaneously. I was responsible for the creation, approval, and execution of installation qualifications, operational qualifications, unit tests, integration tests, user acceptance tests, performance qualifications, stress tests, and system trace matrixes for site computer systems. Show less Continuing my advancement with this position meant additional responsibility including performing Validation and Quality Assurance approval of system documentation, such as functional requirements, design specifications, and installation documentation. I was also the validation team member on a 6-month implementation of the SAP R/3 Sales and Distribution module. In addition, I began defending validation documents for computer systems to multiple regulatory agencies and customers. I also began training other validation and quality assurance staff on computer validation and regulatory requirements. Show less

  • IT Senior Validation Associate

    Apr 2003 - May 2005

  • IT Validation Associate III

    Mar 2002 - Apr 2003

  • Quality Associate III

    Dec 2000 - Mar 2002
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  PharmaE

  May 2005 - Nov 2006

  Project Manager

  I was a validation contractor for a regional validation consulting firm that provided all validation activities from project management activities to document creation and execution. I provided validation services to multiple clients and multiple locations including the implementation of an electronic document management system to house engineering drawings as well as the upgrade of an existing distributed control system.

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  Clarkston Consulting

  Nov 2006 - Aug 2008

  Senior Consultant

  I was a validation consultant for an international consulting firm that provides validation and management services to a variety of life science and consumer product industries. While at this company, I was responsible for the validation activities for the implementation of an existing SAP R/3 system (including the SD, FI, CO, AA, PM, MM, PP-PI, QM, PS, CO-PC, WM, and BW modules) at other client sites in Austria and the Netherlands. I was responsible for the creation and adherence to the timeline, the creation and approval of all testing documentation, and system documentation. In addition, I was responsible for ensuring all activities were completed per business procedures and providing all training for the team as it related to the Validation program, quality, good documentation, and the system development life cycle. In addition, I provided team training on the use of the owning site's electronic document management system. Show less

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  DSM

  Aug 2008 - Sept 2010

  Principal Validation Associate - Systems and Facilities Validation

  This position included responsibilities relating to computer systems, lab systems, and automation validation for the local DSM facility as well as computer validation activities for the business group's sites in Austria and the Netherlands. They included providing input and consensus on proposed changes, coordination of resources and time management activities. I was responsible for defending these systems to auditing regulatory agencies (both foreign and domestic) as well as current and potential customers. I provided training on the validation program and electronic document management system. I reviewed and approved all validation and system documentation as they related to the computer systems, lab systems, and automation systems I was responsible for. I was a team member as necessary for corporate initiatives such as procedural/program reviews, system upgrades, and new system implementations. I provided forecasting scenarios to upper management to assist in the scheduling of production resources and implementation requests. Show less

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  BD

  Sept 2010 - May 2011

  Validation Engineer, Computer Validation

  This position included responsibilities relating to computer systems and automation validation for a start-up facility. I was accountable for the validation of a new implementation of a Process Control System that included working with multiple consultants. In addition, I reviewed and approved validation and system documentation related to automation systems, computer systems, and lab-related software. I worked on providing process improvements for the computer system validation program, the change control system, and the periodic review process. Show less

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  Sequence Inc.

  Apr 2011 - May 2021

  Sequence, Inc. is a leader in providing validation, quality, and compliance consulting services for industries regulated by the FDA. By uniting with our clients, we provide the end consumer with products of the highest quality. Through our knowledge, experience, and integrity, we offer a level of service that is unsurpassed industry-wide.

  • Southeast Regional Manager, IT Quality

    Jan 2020 - May 2021

  • Manager, IT Quality

    Apr 2019 - Jan 2020

  • Western Carolina Regional Manager, IT Quality

    Jun 2017 - Apr 2019

  • Principal Consultant / Team Lead, IT Quality

    Sept 2014 - Jun 2017

  • Senior Consultant

    Apr 2011 - Sept 2014
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  Confidential Client

  Oct 2014 - Aug 2020

  Provided guidance for the implementation of a corporate-wide Quality system through the creation of Policies and Procedures, interpreting FDA Legislation, Regulations, and Guidance documents for the client’s industry. Validation Project Manager for implementation and maintenance of corporate computer systems deemed to have Validation relevance including ensuring creation of appropriate system documentation (requirements, design, configuration) as well as creation and execution of all validation deliverables (plan, risk assessment, IQ, OQ, PQ, traceability matrix). Systems include Pilgrim’s SmartSolve application suite (CAPA, Document Management, Complaints, Non-Conformance, and Change Control modules), as well as two Learning Management Systems, Marketing Resource Management System, and computerized Computer Access Request system.Validation Project Lead for the validation of a multi-facility Manufacturing Execution System, including management of validation timelines and resources, creating system documentation framework, developing Validation testing approach, and establishing communication flows between the client and multiple third-parties to ensure effective Change Management and Change Control throughout Validation Project and on-going system life-cycle. Show less

  • Site Lead/Validation Project Manager on behalf of Sequence, Inc.

    Apr 2011 - Aug 2020

  • Project Manager on behalf of Sequence, Inc.

    Oct 2018 - Sept 2019

  • Inspection Remediation on behalf of Sequence, Inc.

    Apr 2018 - Apr 2018

  • Validation Lead on behalf of Sequence, Inc.

    Oct 2015 - Dec 2015

  • Project Manager on behalf of Sequence, Inc.

    Oct 2014 - Jun 2015
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  Confidential Client

  Mar 2021 - Apr 2021

  Validation Consultant on behalf of Sequence, Inc.

  Provided redesign of existing validation package provided to clients by a GMP software provider. Created user requirements for application and created risk based approach to testing. Created related validation documentation including IQ/OQ protocol, and traceability matrix.

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  Reynolds American Inc.

  Aug 2021 - now

  Senior Manager, Validation Compliance

  • Lead and manage the standardization of enterprise level policies and procedures for implementation of Validation elements across operating companies• Develop framework and processes for Validation-relevant elements in accordance with applicable corporate strategies and regulatory requirements• Manage key Validation initiatives to prepare operating companies for compliance• Manage Change Control for Validation-relevant systems in response to business drivers or new regulation• Oversee contractor/consultant deliverables (project plans, Validation documentation, training, etc.)• Assess consultant staffing requirements and workload distribution for Validation projects and Change Control• Serve as Validation project subject matter expert during FDA inspections• Serve as the back-up Validation subject matter expert to present Validation framework during FDA inspections• Serve as Subject Matter Expert and System Administrator for Kneat Validation Lifecycle Software• Work collaboratively with stakeholders to ensure consistency in approach and the appropriateness of process governance• Seek and implement strategies to increase efficiency of processes Show less