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IT Quality System Manager

1 month ago

Raleigh, United States Infotree Global Solutions Full time

No C2C and/or H1B please


One of our leading Pharmaceutical client is looking for a IT Quality System Manager (Pharma/Biotech/Medical Device), who will be responsible for providing support in the gathering, reviewing, and analyzing of data to inform business decisions. Analyzes program policies and procedures to determine their effect on automated systems and system functional areas. Defines scope and objectives, creates system specifications that drive system development and implementation.


Job Title: IT Quality System Manager (Pharma/Biotech/Medical Device)

W2 Contract & Onsite role

Work Location: Raleigh, NC


Required Experience:


  • Pharmaceutical / Life Sciences environment
  • In-depth knowledge of relevant systems and platforms (e.g., Veeva Vault, RIMS, Submissions, IDMP, etc.)
  • Ability to understand the business needs and translate that into a solution that can be leveraged by multiple customers
  • Track record of excellent task management skills such as planning, prioritization, meeting management and plan execution


Responsibilities:

  • Interact with the business to support the implementation of systems and applications, while also providing ongoing support for new module implementations and/or installation of new capabilities
  • Comply with Software Development Lifecycle and company’s Computer Systems Validation (CSV) process and procedures
  • Actively participate in all phases of application implementation, including ownership of key deliverables such as Change Controls, User Requirements Specification, Function
  • Specification, Design Specifications, Risk Assessments and Validation documentation
  • Deployment & Hypercare support
  • May provide assistance in business case development (i.e., research, data collection).
  • Support development of user test cases, user stories and system integration testing and validates test results during testing.
  • Participate in the review and approval of test plans, and monitors testing process to ensure that business results are adequately tested with minimal risk.
  • Identify and recommend areas of process improvement
  • Perform knowledge transfer and provide ongoing leadership, to support project go-live and beyond, operations and support activities


If you are a right fit and this job excites you then please apply quick