Job Description

Job Summary

The IT Quality & Compliance Specialist is responsible for ensuring that computerized systems supporting regulated business processes comply with applicable regulatory requirements and industry standards. This role partners closely with IT, Quality, and business stakeholders to implement and maintain compliant, risk‑based processes for system validation, change control, data integrity, and ongoing compliance, with an emphasis on Computer System Validation/Computer Software Assurance (CSA) principles.

Key Responsibilities

IT Quality & Compliance

  • Ensure computerized systems comply with applicable regulations and standards, including 21 CFR Part 11, 21 CFR Part 820, EU GMP Annex 11, ISO 9001,ISO 13485 and other applicable global regulations
  • Support internal and external audits and inspections related to IT systems and validation
  • Identify, assess, and mitigate compliance and data integrity ris...

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