Colleen Glavan Email and Phone Number
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Colleen joined DXC in July 2011, in the IT Regulatory and Quality Compliance organization. Her responsibilities include developing and driving a quality process for problem and incident management to steady state excellence, creating and maintaining training content for 800+ personnel, driving software qualification projects to completion, ensuring 100% compliance for audits/inspections in the highly regulated Life Sciences industry, writing process documentation, ensuring the retention of all personnel qualifications for the account and maintaining strong working relationships with all levels of management and peers.Before joining DXC, I worked for Bristol-Myers Squibb in the IT Validation Services department managing validation/qualification projects of hardware/software.Skills: Process Development and Improvement, Microsoft Office, SharePoint, Analytics & Reporting, Audit Support, Training Management, Document Management, Change Management, Problem Management, Personnel Management, HP ALM, ServiceNow, Microsoft Power Platform
Dxc Technology
View- Website:
- dxc.technology
- Employees:
- 83579
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It Regulatory And Quality Compliance SpecialistDxc Technology Apr 2017 - PresentGreater Philadelphia Area•Identify delivery excellence opportunities for continuous improvement•Develop, document, drive, and measure a process to improve the quality of Problem and Incident Management to steady state excellence. o Use Microsoft PowerForms and SharePoint functionality to drive a 12% increase in Problem Quality and 7% increase in Incident Quality•Utilize ServiceNow Dashboard functionality to create dashboards with meaningful reports, displaying real-time data, in support of continuous improvement activities•Create an Operational Performance Pack of 4 Functional Design Documents, intended to act as a “menu” of reports and their purpose for leadership to drive results•Create and drive a process to retain and track the resumes and qualification of over 400 personnel, using SharePoint, with 100% compliance•Ensure 100% compliance for over 100 audits in the highly regulated Life Sciences industry; this includes over 12 Regulatory Agencies and Sarbanes Oxley (SOX) controls•Drive over 100 Software Qualification Projects to completion using HP ALM, ServiceNow and SharePoint by effectively organizing meetings, creating documentation, providing a communication channel for the client, and ensuring compliance with all process documentation•Manage the content creation, modification, review, assignment and reporting for 29 training courses using Lectora Publisher and SABA reporting tools•Lead the qualification project for a ‘Good Practice’ rated Document Management System/Process, used to create, update, publish, and approve over 800 client-related and internal documentso Perform periodic reviews and updates on over 20 documents (SOPS, WIs, STDs) for the Compliance Office and assist document owners through the qualified document management process• Train 7 co-workers on 3 compliance office processes: document management, training management, on/offboarding management•Maintain strong working relationships, internally and client-facing, with all levels of management and peers -
It Regulatory Compliance SpecialistHewlett-Packard Feb 2014 - Apr 2017Hopewell, Nj-Created a process and documentation around the retention and maintenance of a personnel qualification and resume SharePoint site-Provided metrics to illustrate the activity around the Personnel Qualification effort using Microsoft Excel-Provide support for regulatory inspections/audits (SOX, FDA, external, internal)-Supported the Software Qualification Process by effectively organizing meetings and communicating with numerous teams to ensure the timely delivery of qualified tools to the client-Supported the qualification of software by aiding in the creation of documentation used by the client to verify that tools being introduced into the environment have been successfully implemented-Supported the Software Qualification process by working with the client to update and maintain all related documents on a SharePoint site and effectively communicate all changes and comments between HP and BMS-Maintained the Document Management process by acting as the Document Owner for the Compliance Office, overseeing documents before they are made effective -
Regulatory & Compliance OfficeHewlett-Packard Feb 2014 - Apr 2015Hopewell, Nj-Created a process and metrics to measure the retention and maintenance of employee profiles using SharePoint and Microsoft Excel-Provided support for regulatory inspections/audits (SOX, FDA, external, internal)-Supported the Software Qualification Process by effectively organizing and facilitating meetings, communicating with numerous teams, and ensuring the timely delivery of qualified tools to the client-Created internal and client-facing documentation to verify the successful implementation of qualified software-Provided oversight for the Document Management in the role of Document Owner for the Compliance Office -
It/Regulatory Compliance OfficeBristol-Myers Squibb Jul 2011 - May 2013Pennington, Nj• Provided management metrics to illustrate account activity and continuous improvement efforts using Microsoft Excel and PowerPointo Monitored and delivered metrics from the HP client on on/offboarding of employees, document management and maintenance, CAPA progress, Training compliance (LifeSciences and BMS Account)• Supported regulatory inspections/audits (SOX, FDA, external)• Supported the Problem Management and Corrective Action Preventive Action (CAPA) Process for the client with proven success rate on closure of open and past due itemso Provided guidance to the BMS Problem Management team to ensure that information is kept current in the Trackwise tracking systemo Provided weekly metrics of CAPA closure progress• Created a Management and Operations Manual (MOM) to describe the processes and procedures that enable interaction between BMS and HP regarding delivery and support of in-scope serviceso Facilitated meetings with stakeholders to map out processes using the Kaizen meeting strategy -
Information Technology Validation Services AnalystBristol-Myers Squibb May 2009 - May 2011Plainsboro, Nj• Conducted validation of hardware and software changes using Remedy and SAP software o Supported both planned and unplanned changes to software and applications by working with management to ensure approved processes are both followed and documented o Responded to and provide QA Review for applicable Change Requests• Assisted with the review and development of Computer System Validation Requirements, Risk Assessments and Deliverables• Supported server, database and network device qualification processes o Reviewed script outputs to ensure compliance with validation standards and maintain qualification status of assets o Provided guidance to engineers on acceptable documentation standards to support continuous improvement o Maintained and updated qualification records through EPIC STAR and Valdox Document Management Systems to ensure audit trails are maintained• Provided management metrics to illustrate continuous improvement efforts using Microsoft Excel and PowerPoint• Improved qualification process by working effectively with partners of and groups across the company o Re-engineered, managed and supported the qualification process to ensure continuous improvement o Analyzed and identified gaps to create a plan for resolution of problem areas o Conducted meetings to implement and communicate changes across teams to streamline processes• Created Work Instructions (WIs), Standard Operating Procedures (SOPs) and Templates to accurately reflect QA processes o Updated and maintained 5 WIs, 2 SOPs and 6 Templates continuously • Responded to internal/external audit and FDA inspection requests for qualification records and action the remediation efforts for any deficiencies • Analyzed quality assurance contracts with partners to ensure accuracy of the information and prepare assessment for management review • Trained 4 co-workers on the qualification and change management processes and the use of EPIC STAR system for qualification reports -
Information Technology InternAlpha Systems May 2006 - Sep 2008Build, Customize and Update internal websites using Microsoft SharePoint.Worked with Human Resources, Software Development and IT functions to create custom SharePointsites to facilitate document management, data management and information sharingSupport IT security certification process for VeriSign and Safe Harbor by documenting procedures and policies and organizing technical information using Microsoft Office and SharePointCreated Network diagrams, Floor plans, and detailed server rack diagrams using Microsoft VisioProcessed Electronic Discovery data using forensic software tools to cull data for further processing.Managed data batches and performed quality control processes to ensure data integrityPurchase Hardware, Software, supporting equipment and work with IT vendors on pricing and configurations for the IT staff.Manage maintenance contract renewals for hardware and software -
Accounting AssistantAlpha Systems May 2005 - May 2006Support data conversion for new Financial SystemsPerform data reconciliation between existing and new financial systemsEnter Purchasing, Accounts Receivable, Accounts Payable, General Ledger and supporting data into the new system. -
Marketing AssistantAlpha Systems May 2004 - May 2005Assist the marketing department in preparing for their annual conferencePrepare mailing and customer lists, work with the mailing department and put together pamphlets for business meetings -
Data Entry OperatorAlpha Systems May 2003 - May 2004Accurately entered employee data into the Great Plains financial systemScanned, categorized and filed invoices and other company documents -
Computer Lab AssistantRider Learning Center Jan 2006 - Dec 2007Enter data into computers using Microsoft Office to track employees and/or studentsSchedule appointments as the receptionist for tutoring
Colleen Glavan Skills
Colleen Glavan Education Details
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Computer Information Systems -
Business Administration And Management, General
Frequently Asked Questions about Colleen Glavan
What company does Colleen Glavan work for?
Colleen Glavan works for Dxc Technology
What is Colleen Glavan's role at the current company?
Colleen Glavan's current role is Global Digital Assurance at DXC Technology.
What is Colleen Glavan's email address?
Colleen Glavan's email address is su****@****ail.com
What is Colleen Glavan's direct phone number?
Colleen Glavan's direct phone number is (650) 857*****
What schools did Colleen Glavan attend?
Colleen Glavan attended Rider University, Rider University.
What are some of Colleen Glavan's interests?
Colleen Glavan has interest in Health And Fitness, Disaster And Humanitarian Relief.
What skills is Colleen Glavan known for?
Colleen Glavan has skills like Metrics Reporting, Audit Support, Change Management, Problem Management, Document Management, Analysis, Job Aids, Microsoft Office, Visio, Quality Assurance, Sap, Databases.
Who are Colleen Glavan's colleagues?
Colleen Glavan's colleagues are Charanpal Singh, Vanessa Collett, Gunasekaran Thirumoorthi, Elango V., Muqeeb Ansari, Reshma Khanum, Rafal Arel.
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