Quality Manager

Sushma G. Saini

*** ***** ******* **. ************, PA 19438 610-***-****

https://www.linkedin.com/in/sgsaini ************@*****.*** High energy, result-oriented ITIL Certified Professional with expertise in Program/Project and Process Quality management in the Pharmaceutical and Health Care industry. Adept at facilitating and integrating global teams from a variety of disciplines toward the common goal of delivering a quality product. Expertise includes:

Accomplished leader, coach and mentor of individuals

Strong interpersonal and management skills

Excellent customer relationship skills

Keen problem solving skills

In-depth knowledge of Agile and Waterfall methodology and Implementation

Regulatory Compliance, Process definition and implementation, System Integration and Validation PROFESSIONAL EXPERIENCE

E-PHARMASOLUTIONS, PLYMOUTH MEETING, PA 2015 – PRESENT Project and Quality Manager

Supports integration and QA of (CTP) Clinical Trials Portal applications – SFA (Site Feasibility Application), TMF (Trial Master File), SDE (Secure Document Exchange); LMS (Learning Management System, SLD (Safety Letter Distribution). Consults and collaborate with stakeholders on requirements gathering, review and validation. Ensures product quality and regulatory compliance, while driving process effectiveness and efficiency.

Monitors product development and validation from requirement gathering though production deployment and customer support.

Ensures appropriate product development methodologies and procedures are followed.

Coordinated with business and client service team for UAT, deployment and installation.

Directs software development efforts for integration of third party vendors’ software with company products.

Evaluates new technologies and methodologies to determine feasibility of using them to deliver company products. VREEHEALTH (A MERCK SUBSIDIARY), West Point, PA 2013 – 2014 Program & Quality Manager –

Documented, implemented and managed QA and system development processes. Consulted and collaborated with stakeholders on requirements gathering, review and validation (System Validation and UAT). Ensured product quality and regulatory compliance, while driving process effectiveness and efficiency. Facilitated stage gate reviews.

Identified and implemented cloud-based tools for requirement and test management for use in an AGILE development environment, using Qmetry, JIRA and Confluence

Designed and implemented SDLC, supporting SOPs and templates for SDLC deliverables.

Coordinated with business and client service team for UAT, deployment and installation.

Reviewed and/or facilitated review and archiving of all SDLC documents and lessons learned ACR (American College of Radiology), Philadelphia, PA Oct 2012-Apr 2013 Compliance Manager

Supervised GCP group from work and HR perspective. Managed all compliance related processes in regards to development of Agile development process. Reviewed and direct the preparation of IT’s GCP related documentation such as OQ, IQ and PQ for Radiology related applications. Facilitated internal and external audits, corrective and preventative actions (CAPAs). Represented IT during site compliance audits by customers, vendors or governmental agencies. MERCK & CO. INC, West Point, PA May 1999 – Mar 2012 Client Liaison, MRL (Oct 2010 – March 2012)

Managed Merck Research Lab IT portfolio for SV&T, which entailed basic research, preclinical, clinical and licensing applications. Utilized MS Project server to create project plans, managing and maintaining demand planning information. Negotiated contracts ranging from $10K to $100K with internal clients and external suppliers.

Defined, developed and implemented Test Factory process.

Managed SLAs between external vendors and business clients and identified new opportunities for partnership.

Directed deliverables of 150+ onsite & offshore resources, directly supervising tasks of 40+ resources and provided program status to upper management.

Sushma G. Saini Page 2

IT Lead (Aug 2001 – Oct 2010)

Project lead for various applications for handing Clinical Trials and Clinical Trial Data. For example: Clinical Data Entry system, Clinical Trial Management System (CTMS); Clinical Data Adjudication System (CDAS), Clinical Trial Data Migration (CTDM), Clinical Trial Management System (CTMS - a system to handle investigator and site data); Sample Tracking End-point System

(STEpS- a biopsy sample tracking system), Closed Loop Planning & Accounting (CLPA – a capacity planning and management system), Sales Force Automation system, Master Data Repository, SAP- Analytics, Customer Finder, GTMS (Global Timer Management System); GLMS (Global learning Management System;

Managed multiple releases of projects using Agile and/or SCRUM methodology.

Managed multiple releases of subsystems and coordinated and reported on end-to-end system integration.

Defined and managed test environments, coordinated data loads to support multiple teams sharing one environment.

Created and maintained estimates and payment schedules to external vendors.

Coordinated and monitored systems data loads, facilitated issue reporting, analysis and resolution meetings. IT Systems Analyst May 1999 – Aug 2001

Managed integration test lab, validated clinical data collector systems and documented QA process and evidence. Managed audits.

Determined and documented test strategy and plan for projects using different methodologies, specifically Agile/SCRUM for clinical and pre-clinical projects.

Created and delivered presentations to upper management on status of programs.

Created Test Plans, Test Scenarios, Test Cases and Test Summary Reports.

Facilitated User Acceptance Testing.

Mentored Test Analysts to ensure awareness of program, divisional, corporate and industry standards.

Piloted use of Test Director /Quality Center and provided administrator services for MRL IT Test Director. OTHER RELEVANT EXPERIENCE

CONSULTING PROJECTS

Vanguard - System validation of financial systems handling retirement plans and other investments.

SmithKline Beecham Pharmaceuticals: - Test cycle lead for sales force automation system

Merck & Co – Updated software used for Clinical studies.

Sanofi Pharmaceuticals - Validated lab batch data loading system process for clinical trials.

CB Technologies – Designed and developed an internet site Pulmonary Hypertension Association.

GM, Wilmington, DE - Implemented scheduling and project tracking system using MS Project. RDL INC., Conshohocken PA

Mechanical Engineer/Project Manager

Created and monitored project plans using MS Project electronics packages for defense electronics.

Authored general procedures and specifications for Military standard assemblies.

Managed a mechanical engineering test lab for conformance to MIL standard for destructive and non-destructive testing TECHNICAL SKILLS

Management Tools: Microsoft Project Server (MSPS), Microsoft Project, PowerPoint, Excel

JIRA & Confluence, Remedy for Release Management

Clear Quest

Six Sigma

Design for manufacturing

EDUCATION

M.S.in Engineering Management, Drexel University, Philadelphia. B.S.in Mechanical Engineering, TIET, India

Visa Status

US Citizen

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