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IT Business Systems Manager - Quality Systems

IT Business Systems Manager - Quality Systems

JobgetherUS
30+ days ago
Job type
  • Full-time
  • Remote
  • Quick Apply
Job description

About Jobgether

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

One of our companies is currently looking for an IT Business Systems Manager – Quality Systems in the United States .

As the IT Business Systems Manager for Quality Systems, you will act as the IT System Owner for GxP-regulated platforms such as Learning Management Systems (LMS), Quality Management Systems (QMS), and Electronic Document Management Systems (eDMS). Your role will focus on supporting compliance-related applications and partnering closely with Quality and Validation teams to ensure the successful configuration, validation, and operation of systems like Veeva Vault Quality and ComplianceWire. You’ll lead both technical and regulatory aspects of IT system management in a hybrid agile / waterfall environment, driving scalable and compliant technology solutions.

Accountabilities :

  • Serve as IT System Owner for GxP-regulated quality systems (e.g., QMS, LMS, eDMS) and ensure they meet compliance and operational standards
  • Lead system-related IT support activities, including vendor oversight, issue resolution, and adherence to SLA commitments
  • Oversee change control and Computer System Validation (CSV) processes in collaboration with Quality and Business stakeholders
  • Create and maintain validation documentation including impact assessments, test plans, traceability matrices, and summary reports
  • Collaborate cross-functionally to define user requirements and deliver solutions aligned with regulatory and business needs
  • Manage enhancements, upgrades, and integrations for quality systems while ensuring system performance and compliance

Requirements

  • 5–7+ years of experience in the pharmaceutical or biotech industry, with a strong focus on GxP environments
  • Demonstrated expertise in GxP regulations (FDA 21 CFR Part 11, EU Annex 11, ICH Q8 / 9 / 10) and Computer System Validation (CSV)
  • Strong knowledge of Veeva Vault Quality applications (QMS & QDocs); Veeva Vault Quality Certified Administrator certification preferred
  • Experience supporting managed service vendors and ensuring compliance with operational SLAs
  • Familiarity with platforms like UL ComplianceWire, Microsoft SharePoint O365, and hybrid development methodologies
  • Excellent communication, facilitation, and project planning skills with the ability to work cross-functionally and independently
  • Benefits

  • 401(k) plan with company match
  • Inclusive family-building support and paid family leave
  • Flexible time off with additional summer and winter shutdowns
  • Disability and life insurance
  • Reimbursement for remote work setup
  • Career development in a purpose-driven and inclusive organization
  • Jobgether hiring process disclaimer

    This job is posted on behalf of one of our partner companies. If you choose to apply, your application will go through our AI-powered 3-step screening process, where we automatically select the 5 best candidates.

    Our AI thoroughly analyzes every line of your CV and LinkedIn profile to assess your fit for the role, evaluating each experience in detail. When needed, our team may also conduct a manual review to ensure only the most relevant candidates are considered.

    Our process is fair, unbiased, and based solely on qualifications and relevance to the job. Only the best-matching candidates will be selected for the next round.

    If you are among the top 5 candidates, you will be notified within 7 days.

    If you do not receive feedback after 7 days, it means you were not selected. However, if you wish, we may consider your profile for other similar opportunities that better match your experience.

    Thank you for your interest!

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    Quality System Manager • US