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Project Quality Manager Resume

East Hanover, NJ

SUMMARY

  • Senior Project Manager with extensive pharma and biotech experience in Informatics and IT project management, computer systems validation, business analysis, architecture, application support, infrastructure and technology strategy.
  • Experienced in building high performance teams, project plans and documentation, change control, release management, regulatory compliance, managing risk and maintaining strong relationships with clients, vendors and business partners.
  • Primarily support Oncology, CNS and Anti - infective therapeutic areas. Strengths: Leadership, analytical, communication, negotiation and presentation abilities. Assets: creativity, customer focus, “hands-on” problem solving.
  • Successfully completed integration of adverse event and Siebel CRM systems; Implemented ARISg 5.0 Adverse Event Reporting System with E2B gateways
  • Supported Pharmacovigilance in design, development, deployment and support of tools for adverse event reporting, EDC, signal detection, d analysis and prediction
  • Responsible for integration of third-party software applications, vendor management, new product evaluation, business and functional requirements definition, requirements analysis, test planning, test case development and test execution

TECHNICAL SKILLS

  • MS Project Documentum
  • SharePoint
  • UML
  • RUP
  • SDLC
  • LIMS
  • ARISg
  • ARGUS
  • Agile
  • Spotfire
  • EDC
  • MobileIron
  • MedDRA
  • WHO
  • ICH
  • SAS
  • Remedy cGxPs
  • SOPs
  • 21 CFR Part 11
  • CSV
  • PMP

PROFESSIONAL EXPERIENCE

Confidentialm, East Hanover, NJ

Project Quality Manager

Responsibilities:

  • Provide Quality & Compliance oversight for the highest priority projects across the portfolio of 100+ projects annually, with annual budgets totaling roughly $20M, including COTS, internally developed and mobile applications, SaaS, Documentu Salesforce.com
  • Veeva CRM and SharePoint-based platforms. Business groups supported include Medical Affairs, Drug Safety, Clinical Development,(e.g. HR, Finance and Office of the President).
  • Duties require frequent collaboration within and across business units at all levels in the organization, as well as a clear understanding of GxPs and FDA regulations.
  • Provided project management and business analysis for the design, development, installation and deployment of the MINova QUEST medical enquiry and contact management system
  • A project which received the eliciting, organizing, translating and simplifying user requirements, assisting sponsor with the business case, documenting business processes, developing use cases, designing test cases, managing requirement changes, ensuring project quality, contracts and vendor management, assignment of tasks, budget and deliverables tracking.

Confidential, Nutley, NJ

Senior Project Manager

Responsibilities:

  • Responsible for Drug Safety systems initiatives, including a global implementation of ARISg 5.1 and integration of Siebel Participated in the Global Informatics Management Team in defining IT strategy.
  • Prepared and presented business cases. Reviewed, defined and negotiated project schedules and budgets. Conducted Voice of Customer (VoC) surveys and workshops. Coordinated and facilitated User Acceptance Testing (UAT)
  • Managed and cultivated relationships with senior executives, sponsors, other functional areas and third-party vendors.

Confidential

Director/Clinical Informatics

Responsibilities:

  • Completed consulting engagements leading implementation of global solutions for Drug Safety and Clinical organizations, including a major safety system upgrade to ARISg version 5.1

Confidential, Bridgewater, NJ

Senior Project Manager

Responsibilities:

  • Held roles in Software Quality Assurance and Scientific Computing, developing technology solutions to meet business needs. Led teams in global software development for business and drug discovery applications.
  • Led genomics and proteomics dbase applications development and support, including a web-based portal that provided a single point of entry to globally dispersed scientific systems, as well as implementation of a Siebel SFA system.

Confidential, Raritan, NJ

Senior Project Manager

Responsibilities:

  • Led IVD product teams as a consultant to attain schedule goals and business requirements for global Immunohematology product development, a product line representing a $270M annual revenue stream.
  • Responsible for product development, project plans, processes and documentation. Duties included communication of project plans and progress to senior management, risk assessment, budgets, proposals and statements of work.

Confidential, Parsippany, NJ

Senior Manager

Responsibilities:

  • Led a team responsible for product management, marketing, project management and architecture of next-generation networks including IP-based PBX and softswitch platforms. Performed competitive analysis and market research.
  • Formulated project plans, product plans, specifications and requirements. Duties included leadership of cross-functional teams, P&L attainment, building teams, proposals, vendor management, product lifecycle management
  • Business plans, white paper generation, trade show support and product launch. Frequent interaction with customers and senior management.

Confidential, Murray Hill, NJ

Senior Manager

Responsibilities:

  • Coordinated and developed Bell Labs’ global R&D and product line plans linking research, business, and market strategies to product line and technology plans.
  • Provided strategic planning expertise and consultancy to the Bell Labs scientific community, reporting to the CTO. Duties included strategic planning
  • Technology assessment, competitive analysis, project management, development of department web site and market research.
  • Helped formulate technology acquisition and intellectual property strategies for corporate executive leadership.

Confidential, Whippany, NJ

Lead Engineer

Responsibilities:

  • Led a team of 15 computer scientists and engineers in the development of mobile networks. Attained a drastic reduction in faults and product development interval for the Flexent platform, the culmination of a $200M R&D effort.
  • The successful deployment and subsequent release of the Flexent platform, on time and with virtually zero defects, was a first for the division.

Confidential, Nutley, NJ

Asst/Scientist

Responsibilities:

  • Served an Advanced Placement internship while attending high school. Responsible for the performance of pre-clinical research experiments under the direction of Senior Scientists.
  • Familiar with lab practices, in vitro/in vivo screening, cell culture, sample extraction and purification, design of experiments, HTS, DMPK, d analysis, sterilization techniques, cGLP, FDA Compliance
  • Mass Spectrometry, Fluorescence, HPLC, GC, TLC, Immunoassays and report generation. Planned and participated in laboratory research in the therapeutic areas of atherosclerosis, osteoporosis and thrombosis. military

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