Aaron Marsh Email & Phone Number

Cambridge, Ma, Us

Cambridge, Ma, Us

IT System Owner of Quality Management (Trackwise) and Document Management (DocCompliance) systems. Responsible for IT application teams, business area engagement, project delivery, and system health.

Cambridge, Ma, Us

IT System Owner of GMP Document management systems, primarily QUMAS DocCompliance. Responsible for functional area SME relationships, project delivery, vendor engagement, and system health. Implemented cross-functional governance team spanning Quality, Manufacturing, R&D, and Commercial groups. Managed vendor engagement, project and run budgets, and annual license renewals. Delivered new DocCompliance (4.6) build to address issues caused by 2x storage and 4x user growth beyond design limit of current architecure. Included development of a custom Business Objects Universe and 30 new reports and a paperless tablet solution for Internal Manufacturing.Implemented Veeva Quality Docs EDMS for Bioverativ spinoff project (delivered in 7 weeks). Led system design sessions (including definition of business process’) and system configuration workshops with vendor/business teams. Migrated 4K documents from Biogen EDMS including data transformation and validation. Designed training and business readiness plans for go-live.Led 3rd party system health assessment of DocCompliance and TrackWise platforms. Led user assessment sessions, facilitated readout, and designed roadmap to address gaps found with myCIMS EDMS.

Cambridge, Ma, Us

Primary IT site support for Quality Control Labs, Quality Assurance, and GMP Training teams in Massachusetts, Cambridge and Weston facilities.Delivered Oracle Business Intelligence Enterprise Edition solution to US Supply Chain Quality Organization. Included production order dashboards combining product data from OPM R11 and Trackwise QMS and led GMP Qualification of the Oracle Business Intelligence platform. Implemented electronic issuance of production records using QUMAS DocCompliance. Project reduced time (by half) to issue production records to internal manufacturing. Included issuance of serialized production records, and configured print permissions and audit trail needed to enable non-QA personnel to print records in the manufacturing plant.Designed and delivered SharePoint solutions to global Quality Control organization. Included an expedited test request tracking for Global Sample Control team, team management and communications site collection for Global Organization, and the formation of a global business authoring group to manage QC team sites.

Cambridge, Ma, Us

Drove successful completion of Plant Engineering Audit Response stemming from FDA Inspection. Portfolio Manager for 14 projects, met all commitments under demanding time and resource constraints. Responsible for multi-site leadership team managing deliverables at Cambridge and RTP. Evaluated quality systems design of cGMP enterprise applications and performed GAMP/Part 11 systems analysis of Cambridge cGMP operations in support of a global organizational restructure.

Cambridge, Ma, Us

Led cGMP Electronic Document Management System support for Cambridge. Developed global communications strategy and managed update of non-validated reports for system upgrade. Resolved account cycle time delays by aligning with new cGMP Competency Based training system. Managed training schedule, accounts, and migration of 1,600+ Item Specifications from paper system. Orchestrated ongoing effort to migrate all business critical data from MS Access to SQL Server. Functioned as development lead providing physical database design, creation of data migration tools, user requirements, functional specifications, testing plans, and integration of MS Access applications with SQL Server via ADO/ODBC.Resolved widespread recurring MS Access issues stemming from user level security by developing a Java authentication application leveraging Active Directory. Repaired MS Access applications supporting rollout of Office 2010 at Cambridge and Denmark Sites.

Cambridge, Ma, Us

Designed and launched intranet site for global user community, led migration of 350 QC Forms from legacy paper system, developed reporting solutions, managed accounts and training in support of cGMP Electronic Document Management System.Extended reporting and administration functionality of manufacturing documentation change over management application and deployed for use at North Carolina facility.Developed comprehensive reporting application for managing cGMP documentation cycle time and deployed for use by Cambridge, North Carolina, Denmark, and Corporate Quality organizations.Designed, implemented, and managed a best-in-class “Grassroots” continuous improvement program.

Cambridge, Ma, Us

Streamlined account management process for cGMP Electronic Document Management System and coordinated rollout at North Carolina and Denmark facilities. Established Cambridge site training team. Managed revision of training materials, training schedule, and document migration. Integrated data from legacy and current Electronic Document Management Systems and developed reports to remediate duplicated effort saving over twenty hours per month.Designed manufacturing documentation change over management application in support of concurrent multi-product manufacturing. Reduced time to release documentation by providing an efficient mechanism for process control.Created cGMP Archives inventory management system providing immediate location of on site and off site archived records greatly increasing retrieval of documentation during regulatory inspections.Managed schedule and logistics for rollout of Windows XP to Cambridge Site Quality group.

Cambridge, Ma, Us

Managed training and accounts, document migrations, and data mining for cGMP Electronic Document Management System. Coordinated rollout of system at Canada Site. Developed cycle time tracking tools, reports, and automated cGMP forms. Provided technical support for regulatory inspections.

Cambridge, Ma, Us

Participated as core team member for configuration and roll-out of cGMP Electronic Document Management System. Drove upgrade of MS Access metrics and tracking tools, reports, and automated cGMP forms. Advised implementation of electronic production record issuance at North Carolina facility.

Cambridge, Ma, Us

Played a key role in the development of procedures and the structure of the department including design of a 21 CFR Part 11 solution for electronic issuance of production records.

Alm Information Management Systems, Harvard Extension School

Bachelors - Music Business