Program Manager Resume Summit, NJ - Hire IT People

SUMMARY:

Senior IT Program Manager with over 10 years in Life Sciences with diverse experience in Project & Program Management, Software Development Life Cycle (SDLC) and SLAs of various IT Systems in a regulated environment within Healthcare.Known for establishing outstanding relationships with clients and vendors, possessing strong business knowledge, conducting effective communication with all levels of management and working well with diverse groups.Key competencies:
Big picture perspective
Implementation of PM and IT Governance best practices to achieve long - and short-term goals.
Collaborative manager, effective at negotiating win-win outcomes.
Extensive experience in Pharmaceuticals & Healthcare Business Processes.

PROFESSIONAL EXPERIENCE:

Confidential, Summit, NJ

Program Manager

Responsibilities:

Delivered on interim solutions to support analytical & digital priorities. This enabled 75% better reporting capabilities & increased sales growth by 20% & revenue by 10%.
Created and maintained the 2010/2011 MCC IT Commercial Portfolio & Profit Planning (Business Operations decks, scorecards, resource sheets, portfolio progress charts, MOPPS etc.).
Assisted with multi-year roadmap planning/LROP to align with MCC Business Strategies.
Base lined 2011 portfolio estimates to plan and develop 2012 MCC IT profit plan.
Planned contract resources needed across commercial programs to ensure MCC IT had the right talent base to deliver against its portfolio. This reduced project costs by 10% and reduced project delivery times by 1 month. Worked with vendor to prepare SLAs around contract resource acquisition and on-boarding.
Worked with Infrastructure to support the MCC Portfolio/Demand Management process that ensured investments were tightly aligned to the global MCC Business Strategy with measurable outcomes.
Acted as a liaison between MCC IT & Infrastructure to develop SLAs, determine critical success factors, define and manage service expectations.
Participated in Portfolio exchange sessions with Confidential 's IT Infrastructure group to plan and ensure service delivery of ongoing and future programs.
Ensured all MCC IT commercial projects adhered to and complied with Confidential 's SDLC.
Engaged with vendors to evaluate fit and feasibility of third party solutions and services.

Confidential, NJ

Project Lead

Responsibilities:

Developed & managed the project schedule, status reporting, risk management/mitigation, milestone tracking, etc. within budget and scope
Ensured that all work was conducted in accordance with corporate SLAs, SOPs, FDA regulations and guidelines pertaining to Computer Systems Validation, Good Documentation Practices.
Coordinated with the QA/ Validation teams to successfully validate implemented systems.
Acted as Subject Matter Expert in conducting prototype and designed review sessions with business.
Facilitated business teams in analyzing complex issues to meet business needs and define system requirements
Worked with Infrastructure teams to ensure project architecture needs are met, Installation/Operational Qualifications of hardware & application software are completed as per documented validated procedures. Assisted with developing and monitoring post production support SLAs.

Confidential, Piscataway, NJ

Sr. Business Analyst

Responsibilities:

Recommended solutions to existing business process flows to increase efficiency and improve existing processes.
Facilitated design review sessions as required, and ensured that Corporate SOPs and methodologies are strictly adhered to.
Developed System Design Specification documents and Installation Qualification protocols for each application. Reviewed Validation Plans, Summary Reports, Traceability Matrix OQs / PQs.
Prepared Work Instructions, General System Use, Local System Administration and Global Administration SOPs for GQT.

Confidential, Kenilworth, NJ

Sr. Systems Analyst

Responsibilities:

Worked with vendor to develop validation documentation including User and Functional Requirement Specifications, Testing Plans & scripts, summary reports.
Managed and coordinated the System and Integration testing, and assisted in Performance Qualification/User Acceptance Testing.
Managed the report validation initiative for Pharmacovigilance CAPA project that involved leveraging the Periodic Safety Update Reports (PSUR) generation to create product lists and definitions for 60 products reported to the EMEA as per the company’s CAPA commitment.
Implemented Global Applications Change Control System to meet the SOX Objectives for tracking the changes made to the financial systems.
Implemented Labeling Tracking & Global Regulatory Affairs Commitment Tracking, both 21 CFR Part 11 compliant IT systems.
Led the testing team during System, integration and Regression testing.
Developed and executed test scripts for Functional, System Integration, and Regression testing for two Documentum applications in compliance with applicable GLP and GMP FDA regulations.