Project Manager

2 weeks ago

Cambridge, Massachusetts, United States Cognizant Full time

Cognizant Technology Solutions is seeking for "Project Manager "who could join in our team of IT professionals in a permanent role. If you meet our background requirements and skills and looking for an opportunity to be rewarded for your skills and expertise, here is the ideal opportunity for you

Roles & Responsibilities

  • . GxP Computer System administration, support escalation point, and maintenance
  • GxP Computerized System Incident Management and technical investigation
  • Creating SOPs, Guidance Documents, and Work Instructions
  • IS SME who partners with QA on managing GxP enterprise applications throughout all phases of the system development lifecycle, including concept, design, implementation/validation, and operation
  • Information Systems SME and a representative that serves as a Project Manager
  • Supporting account management, routine user access reviews, and release management for GxP 30+ regulated systems
  • Effectively interface with system business owners of GxP systems and provide technical support
  • Effectively interface with vendor support and maintenance & operation of the GxP systems
  • Staying current with US and international regulations, industry standards, and emerging topics pertaining to GxP CSV, SDLC, GAMP5, GCP and GMP
  • Preparing, reviewing, and approving GxP Computerized Systems Validation lifecycle documents as an IT SME
  • Assisting in the creation and capitalization of validation tasks necessary for the project scope and objective
  • Actively participating in Project Meetings and Walkthroughs

Minimum qualifications


• Minimum 5 years of hands-on technical IT experience


• Minimum additional 3 years of experience supporting GxP (GMP, GLP, GCP) computerized systems


• Associate's degree in a related field or relevant experience


• Full understanding of CFR Part-11 rules and their application to regulated and validated (GxP) systems


• Familiarity with System Development Lifecycle and GAMP5 methodology

Nice to have:


• Experience in the life sciences industry and working knowledge of FDA and EU regulated environments


• Experience with on-premises, hosted, and cloud/Software-as-a-Service (SaaS) delivery models


• Proficient in communicating organizational policies and procedures


• Experience in Change Control, incident response, and release management


• Previous experience in validating both cloud-based and on-premise GxP solutions for their intended use


• Ideally familiar with GAMP5, Annex 11, or 21CFR Part 11


• Working knowledge of IT security best practices


• Strong ability to work in a cross-functional team environment with excellent interpersonal and communication skills


• Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, and Optimism

Applications will be accepted until 06/15/2024

The annual salary for this position is between $[100-140K] depending on experience and other qualifications of the successful candidate.

This position is also eligible for Cognizant's discretionary annual incentive program, based on performance and subject to the terms of Cognizant's applicable plans.

Benefits: Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:

  • Medical/Dental/Vision/Life Insurance
  • Paid holidays plus Paid Time Off
  • 401(k) plan and contributions
  • Long-term/Short-term Disability
  • Paid Parental Leave
  • Employee Stock Purchase Plan

Disclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.

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