Manager Project

Raja Mallepeddi Ph.D, PMP

Cell: 609-***-**** email: ***********@*****.***

Profile Summary

Experienced IT QM CSV Manager with over 18 years of experience in managing & leading large-scale Clinical, EDC, E-Commerce, global marketing, retail, digital and web application projects working for world-class major companies like HP Inc.,Covance Inc. and multi-national pharma companies Novartis and Pfizer. Many years of experience in managing CSV, user acceptance testing (UAT)to ensure test planning and execution. Adept at carrying out testing procedures according to the highest possible standards. Specialize in efficiently managing QA, UAT and related business resources. Expert in delivering projects utilizing methodologies including Agile, waterfall and extreme programming with globally distributed teams. Proficient in managing continuous integration projects utilizing SCRUM methodologies, adept in schedule & task management, budget & capacity, risk management, project & program plans, executive leadership metrics & reporting, daily & weekly dashboards for internal and external clients, build automation, functional test automation, managing key performance indicators (KPIs) measuring progress against short and long-term goals. A proven Project Management skills with broad functional and technical experience with noted ability to manage and deliver large and small-scale projects on-time and on the budget in a fast-paced environment under tight deadlines, working with globally distributed stakeholders and senior leadership team. Highly Motivated, dedicated, and proactive. Professional accomplishments

- CURRENT ROLE: Working as a Technical consultant to oversee ecommerce global QA operations at HP Inc. and managing Salesforce, eCommerce project deliverables including overseeing application testing tasks.

- IT EXPERIENCE: Overall 18 years of experience in the IT industry, at various levels and roles as IT validation manager, as Test lead, validation specialist and as a Scrum Master

- Pharma industry Experience: 14 years of experience in Pharma as a validation manager and CSV specialist

- EDUCATION: Ph.D. in Mathematics from BHU, India

- Project Management Professional (PMP)

- Certified Salesforce Administrator

- Experience with AWS and Azure (HP Data center migration project)

- Data Science: R Basics from HarvardX

https://courses.edx.org/certificates/dbd1d04879d24d0396b87fc19ab2135

- IT TEST and Validation MANAGEMENT: Proficient in managing projects with competing priorities and tight deadlines from scope to delivery & implementation including scope management, project & program planning, quality and performance management, budget management, resource procurement, and risk management. I am well versed in partnering with cross-functional teams including business, Development, integration and external vendors with several teams located in multiple locations across the globe. Expert in creating strategic plans for executive decision making.

- CLINICAL SYSTEMS:Experience with clinical technologies; e.g.EDC, GAMP, IRT, CTMS, HP ALM, IVRS/IWRS, IxRS

- PROJECT REPORTING: Well experienced in project reporting, providing transparency to project and senior leadership teams regarding overall project health, distributing and managing daily, weekly, monthly project dashboards, root cause analysis reports, burn down charts, resource productivity metric, identifying and measuring progress against key performance metrics (KPIs). Proven ability to manage upwards and present to executives

- DELIVERABLES: From inception to implementation, I own, maintain and distribute all project documentation, including requirements, product specifications, project/program plans, test plans, and release & implementation notes.

- Expert in managing continuous integration,integrating functional & performance automation with daily builds, leading the automation efforts with the QA, Dev & performance teams, expediting rapid resolution in my projects

- Salesforce: Working knowledge in implementing and maintaining the Salesforce configuration, schema, custom objects, and workflows across Sales Cloud instance 1

- RISK & GLOBAL TEAM MANAGEMENT: Skillful in working with cross-functional teams involving competing priorities and globally distributed teams, addressing and standardizing communication, process, issue resolution plans, and risk management & mitigation. Excels at maximizing a team's potential while delivering timely quality projects within budget Work Experience

Hewlett Packard Inc., Technical Consultant Feb. 2019 - Mar2020 Working as a QA Technical Consultant and managing multiple vendor QA groups. Responsible for implementing QA activities of eCommerce,digital and DC migration activities. Also responsible for test management of Salesforce CRM applications; managing scope, KPIs, weekly leadership updates, and working with business and 3rd party vendors to ensure project QA deliverables on-time.

● Manage testing activities of DC migration activities ( AWS), eCommerce and digital applications

● Established annual Deployment/Release Calendar (collaborating with Business leads and DEV Directors) depicting all milestones and deliverables throughout entire Systems Development Life Cycle (SDLC)

● Partnered and collaborated with the cross-functional resource and project managers from the enterprise teams.

● Managed testing of various Salesforce.com standard objects like Reports and Dashboards, Leads, Accounts, Contacts, and Opportunities along with Campaigns.

● Ensure repeatable test strategies and approaches are in place, guiding efforts to build a Regression and UAT Test Case repository, leading resources to meet project goals.

● Working as a scrum master and helping Scrum teams, System team and development managers to refine a strategy for releasing components and reducing dependencies

● Generated and distributed key performance metrics with the project status and managed stakeholder expectations and communication as appropriate for the tasks and projects, keeping overall goals in mind. Established KPIs and measured progress against the key indicators.

Covance Clinical Development Services, Princeton

EDC Validation Manager June.2017 – Dec.2018

● Span and control of QA leads within multiple businesses and QA functional units.

● Developed QA teams at multiple global locations (US, China, India) and provided the required training.

● Managed over 3 million for QA efforts for all assigned projects, partnering with development, business, and service providers

● Maintains staff by recruiting, selecting, orienting, and training employees; developing personal growth opportunities

● Managing the program life cycle from system design through integration, verification via requirements-based execution, quantitative risk management, and formal change management techniques.

● Create supportive IRT documents and provide system demo to the study team as part of the system acceptance process..

● Embraced, educated and introduced several process improvements to meet changing business needs, following IT policies and procedures, including change control, project management methodologies.

● Prepare final validation and release to production documents.

● Coordinates with the EDC programmers and/or 3rd party vendors in the setup and testing of electronic data capture (EDC) technologies such as Interactive Response Technology (IRT), electronic patient reported outcomes (ePRO), and electronic clinical reported outcomes (eCOA) as required per the scope of work.

● Generated and distributed key performance metrics with the project status analyzed data and managed stakeholder expectations and communication as appropriate for the tasks and projects, keeping overall goals in mind. Established KPIs and measured progress against the key indicators.

Covance Clinical Development Services, Princeton

Testing Manager - CSV Oct.2009 – May.2017

● Managed onsite and offshore validation teams plus vendor resources in the US, China, and India

● Established vision for the QA team and drive quality initiatives across all quality assurance teams within Covance.

● Provide leadership and direction to the Validation Engineering team to accomplish all team goals and objectives

● Developed Test Plans, integration plans, Data migration plans, Traceability, Summary reports and final validation reports.

● Ensure repeatable test strategies and approaches are in place, guiding efforts to build a Regression and UAT Test Case repository, leading resources to meet project goals.

● Work with internal and external customers to identify and implement improvements within the Technology department related to system development life cycle (SDLC) and change management business processes

● Served as a subject matter expert and supported internal and external audits with clients and health authorities.

● Coordinate with end users and process owners to lead development of validation protocols

● Write and approve validation and UAT scripts and summaries for assigned studies where UAT methodology is employed; track defects and support resolution using HP ALM.

● Validate data integrity at different phases of the project life cycle.

● Experience in the implementation of IT security policies to comply with Covance standards.

● Worked with users, Dev IT and management to design and implement workflows, validation rules, reports and dashboards utilizing a systematic and scalable approach to improvements 2

● Introduced innovative methodology and introduced auto data comparison tools and saved over a million dollars annually Novartis, Parsippany, NJ (via RCM Technologies) Sep.2007– Sep.2009 Senior Technical Consultant

● Owned and managed all project documentation including scope, test plans, user acceptance plans, risks and mitigation plans by working closely with business owners, resource managers, architects, development and environment & infrastructure teams.

● Delivered projects on time by effectively applying agile project management methodologies enforcing project delivery standards across the board. Generated several agile reports utilizing tools like JIRA and Rally for daily burndown charts, Kanban reports and key quality metrics identifying issues early in the execution process.

● Managed resource capacity planning and project budget and cost analysis, providing feedback to the leadership team. Identified key risks with budget or resource constraints and mitigated them by working with key stakeholders.

● Ensures that work is performed in compliance with cGMP, GDP, GLP, SOPs and established corporate policies and standards

● Involved with HP ALM workflow implementation and used for validation activities.

● Developed IQ, OQ, PQ and UAT test scripts and implemented UAT and regression and performance tests

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BCF, Burlington, NJ Aug.2006-Sep.2007

DevOps QA Lead

● Managed WB, rDMS and EDI Gateway QA teams and 3rd party contractors

● Led WB, rDMS, EDI, COAT.com and Oracle upgrade implementations

● Analyzing and monitor performance bottlenecks and key metrics to optimize software and system performance

● Development of the company's internal CI system, providing a comprehensive API for CI/CD

● Coordination between the development team and the IT department for development environment maintenance

● Develop, Maintain and support Continuous Integration framework based on Jenkin

● Worked on SDLC (Software Development Life Cycle), from requirements, development, QA, Build & Release management and post-release monitoring

● Developed and executed regression & Performance tests on coat.com image servers, EDI Gateway projects using QTP and LT. Novartis, Parsippany, NJ (via RCM Technologies) Jan.2005– Aug.2006 Senior IT Consultant – QA

● Worked as a workflow lead on the successful implementation and maintenance of the quality center

● Implemented test strategy for Trial Client, Trial Database and Trial Server and prepared environment for EDC applications. Developed test strategies for Server upgrades

● Conducted root cause analysis on a critical server, database, and front-end issues

● Developed QTP for regression tests and LR scripts to test the performance of the EDC application. Previous Experience Jan.2004-Dec.2004

● Software QA consultant, Pfizer

Recognitions

Received several awards for my outstanding efforts and performance in the last 10 years including employee appreciation & Covance internal recognitions.

Skillset

● Programming:C++, Java, JavaScript, Selenium, Python, R, Shell

● SQL & No-SQL Database technologies:Oracle, MongoDB, MySQL

● Cloud Technologies/vendors:Migration from on-prem to cloud, AWS, Azure, Salesforce

● Project Management Tools:MS Project, SmartSheet, Power BI, MS Office, an expert in Excel & Powerpoint presentations, JIRA, HP Agile Manager

● Others:GxP, GAPM, InForm, Medidata Rave, Veeva Vault record management system, Salesforce, Visualforce, Apex Data Loader, Informatica power center, HP Quality Center, HP ALM, CTMS, Documentum,eSignatures, electronic documentation tools, ServiceNow, SAP, SharePoint, Jira, Cucumber, Jasper, ServiceNow, CI/CD, Dockers, Jenkins GitHub

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