Quality Assurance Manager

ADI DANDAMUDI, MBA, PMP

732-***-**** or 860-***-**** ***.*********@*****.***

SUMMARY

Over 13 years of combined experience in areas of relational database, web applications, program/ project/

resource management. Excellent problem solving skills with the ability to effectively communicate complex

technical information to non-technical audiences. Successfully managed systems in GxP environment, multi-

site/ global systems and have clear understanding of Pharmaceutical industry. Skilled in all facets of the product

development life cycle from analysis and design through development, implementation, documentation and user

training. Interested in pursuing a career in Pharma, Finance, Banking, Insurance or Healthcare industries.

SPECIALTIES

Data & Document Management Business analysis

Project Management PMI Certified Production Support

Risk Management Computer Validation

Project Costing Quality Assurance

Change Management Systems Life Cycle Management / SDLC

IT Portfolio Management Enterprise System Management & Delivery

PROFESSIONAL EXPERIENCE

Trainings & Education May 2009 - Present

Six Sigma Black Belt Certification at Southeastern Connecticut State University (Oct 2009 to Dec 2009)

Completed training in Data Mining, Data Warehouse, Project Estimating Techniques, Data modeling, MS Visio

and other trainings by SkillSoft (Jul 2009 to Sept 2009)

Full-time MBA graduate student at University of New Haven (May - Jun 2009)

2006 – 2009

Pfizer, Inc, Groton, CT

(Aug 2007 – May 2009)

Production Support & Site Implementation Manager

Rolled out enterprise solutions and enhanced existing systems with new features and performance improvements

in support of automated data collection and reporting for preclinical data and customer relationship management

for Discovery Biology, Pharmaco Dynamic & Metabolism (PDM) and Comparative Medicine (CM)

departments.

Simultaneously managed multiple projects in support of CM, Biology and PD M departments using Agile,

Waterfall and iterative methodologies.

Integrated data from Granite protocol management system, in-house developed ordering system, and

Business Objects reports, into one solution resulting in 10% time savings for users.

Managed updates to BO universe and Brio reports in support of financial and custom reporting needs.

Worked with infrastructure teams to implement new authentication (PxED), upgrade of Business Objects,

SharePoint and Citrix for multiple systems.

Performed Business Analysis for outsourcing workflow of Antibody labs for Peptide and Antibody work.

Oversaw the work of off-shore development team that developed a viable solution within LabVantage

Sapphire system.

Increased automation lab productivity by 5% and lowered the IT support cost by 30% by designing and

implementing a data curation tool that executed scripts on demand and rectified data discrepancies across

multiple systems.

Reviewed trouble tickets, production rollout schedule, training plans and identify any improvement

opportunities. Achieved or exceeded SLA targets more than 95% of the time.

Provided level 2 & 3 support for the 3 departments for both vendor and in- house developed systems and

managed production support staff members.

Conducted review of process and recommended corrective actions that lowered support call volume 20%.

Developed and executed data migration & retirement plans for systems in accordance with GLP a nd 21 CFR

Part 11 regulations.

Adi Dandamudi

PFIZER, INC. (Continued)

(Nov 2006 – Jul 2007)

Program Manager

Managed support of production systems and developed new strategies to efficiently capture data for CM.

Developed a long-term IT strategy that automated data capture and reporting across 5 US and UK sites and

articulated integration with other corporate systems.

Conducted feasibility & architectural assessments and secured capital funding of $3M.

Managed data migration using informatica 6.0 to move data form legacy system Antrak to Granite .

Negotiated software licensing terms a nd monitored system usage reducing licensing cost 30% (~$150K).

Conducted vendor feedback sessions across multiple sites to improve the product utilization, resulting in

reduced user errors and training opportunities.

(Mar 2006 – Oct 2006)

Technical Lead

Performed architectural and development oversight for enterprise solutions for Global PDM & CM systems.

Developed architectural diagrams and implementation plans for Thermo’s Galileo & Watson upgrades,

managed upgrade of WinNonLin to monitor concurrent user license.

Managed load testing using Mercury tool sets for Galileo upgrade.

Developed database views and informatica ETL mappings for in-vivo and in- vitro data loading to scientific

warehouse data mart.

Created & implemented an off-shore support plan for support of Granite system for all of US.

Pfizer Inc. Ann Arbor, MI

(May 2000 – Mar 2006)

Program/Project and Resource Manager

Responsible for all aspects of SDLC for multiple (30+) projects in Pharmaceutical industry ranging from site

based to global systems for Research & Clinical Quality Assurance, Comparative Medicine, Drug Safety and

Evaluation and informatics departments located in Canada, France, Germany, UK and US.

Managed data capture and reporting needs for Study Protocols, Animal Purchasing, Animal In- Life data,

Animal Breeding Colony, Necropsy, Pathology, Toxicology, Histology, ImmunoHistoChemistry, Imaging,

Data Archival, Robotics, Quality Audit Scheduling, Tracking & Reporting, Facility Audits, Workflow

systems, Budgeting and Portfolio tracking, Inventory tracking, Infrastructure Consolidation and

Departmental Websites.

Managed projects schedule, scope, cost and quality. Generated EVM and reported to management.

Contributed towards the design and development of Toxicology data warehouse as SME for source systems.

Developed a workflow system in support of electronic safety protocol.

Designed and implemented systems that not only mirrored current Business Processes but also

accommodated moderate changes in process.

Managed systems migration during server consolidation and data center migration for 3 departments .

Managed Data migration activity using oracle scripts to move data from legacy systems .

Performed systems integration for 3 departments during 2 Merger & Acquisition.

Reduced IT systems cost by 20% by designing flexible systems that could be used for general data capture

and reporting, this could be customized for diverse departmental needs across multiple sites.

Managed vendor system validation, implementation and contract negotiation.

Wrote User Manuals, Training materials and held training sessions for 300+ users .

Site implementation lead for rollout of new Software Development Life Cycle (SDLC) Methodology.

Managed careers for 5 - 15 resources at times over the 8 year period.

Intern & Consultant at Parke-Davis, Ann Arbor, MI

(Sept 1997 – Apr 2000)

Lead Developer/ Project Manager

Developed data capture and budget tracking systems, individually or led a team of 3, in support of Clinical &

Research Quality Assurance (QA), Regulatory (for Electronic Records Submission) and Comparative Medicine

departments.

Developed and Integrated crystal reports & metrics into QA web applications.

Managed or led the development of 8 in-house web applications and a LIMS implementation project.

Saved $150K by persuading 30 labs to reduce the contracts from 30 to 1.

Adi Dandamudi

(Jan 1996 – Jul 1997)

Graduate Assistant at Eastern Michigan University, Ypsilanti, MI

Developed systems and websites in support of AmeriCorps & Office of Academic Service Learning at EMU.

Designed and developed an application using FileMakerPro. This kept track of the employees, volunteers,

Schools and clubs involved in the program for AmeriCorps. The various reports generated helped in

reporting the information to the Michigan Americorps.

Designed and maintained websites for Office of Academic Service Learning and the Americorps at

EMU.

EDUCATION & CERTIFICATION

MBA University of New Haven, West Haven, CT, 2009

MA Math & Computer Science, Eastern Michigan University, Ypsilanti, MI

Bachelors in Engineering Nagarjuna University, A.P, INDIA

PMP Certification Project Management Institute, 2009

Business Analysis Boston University

TECHNICAL SKILLS

UNIX, Windows 95/98, Windows NT, Windows 2000, XP, MS-DOS

Operating Systems:

Java, C, C++, Microsoft Visual Studio .NET, FrontPage 2000, Visual Basic

Software / Languages:

4.0/5.0, Microsoft Access, Microsoft Word, Microsoft Excel, PL/SQL

Developer 4.0, Oracle PL/SQL, ProC*, Pascal, FORTRAN 77.

Oracle7.1 & 7.3.4 & 8.1.6 & 9i/10g, MS Access 2.0 & 7.0, MS SQL Server,

RDMS:

File Maker Pro, Fox Pro.

Internet / Web Technologies: Microsoft .NET Active Server Pages (ASP), JSP, XML, JavaScript, VBScript,

HTML, Cold Fusion 2.0&3.1, Informatica 6.0 & 8.1

WebLogic 6.1 SP2 & 8.1 SP4/9, IIS 3.0/4.0, Tomcat, WebSphere

Middleware:

GUI’s: MS Visual InterDev 1.0/6.0, Visual Basic 4.0/5.0, Front Page 97&98, Oracle

Forms 4.5, Seagate Crystal Reports 4.5, 5.0 & 6.0, Business Objects 6.5 & Xi,

PhotoShop 5.0

LiveLink, Documentum, SharePoint, OpenLab, OneNote

Content Management:

Visual Source Safe, SQA Suite 6.0, Info Modular, Visio, Mind Manager,

Other:

Viewlet Builder, Mercury Load Runner and Quality Center, Toad, Erwin,

IText, AJAX, EJB, Struts, SOA, Web Services, MS Office, MS Project, MS

Project Server, Datawarehouse and DataMining.

Titian Mosaic LIMS, Cerner Millennium LIMS, IDBS BioBook, Watson,

Vendor Systems:

Galileo, Provantis NT, Waters Millennium 32 LIMS, Sapphire, Granite,

BiaCore, Cellomics Arrayscan, WinNonLin, Bliss, ADP, NanoZoomer.

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