IT&Q Compliance Manager

~35 - 39 EUR/ godz.B2B
MidFull-time·B2B
#384403·Dodano wczoraj·0
Źródło: nofluffjobs.com
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Tech Stack / Keywords

ComplianceGXP

Wymagania

  • Experience supporting at least 1–2 GxP or business-critical systems in the pharmaceutical industry.
  • Experience working in regulated IT environments (Pharma GxP).
  • Knowledge in quality, IT compliance, or validation; software quality experience is a plus.
  • Familiarity with digital product development processes and agile methodologies.

Obowiązki

  • Ensure compliance of digital solutions and IT systems with IT&Q requirements, SOP procedures, and applicable standards.
  • Advise project teams on applying IT&Q procedures, guidelines, and templates.
  • Conduct IT risk assessments using ServiceNow IRM and implement Compliance by Design approach.
  • Define and monitor risk mitigation actions and control mechanisms.
  • Oversee IT solution compliance across the entire system lifecycle from design, validation, implementation to maintenance.
  • Support system owners and product teams in compliance and IT governance.
  • Ensure compliance with information security requirements and Data Integrity principles, especially for GxP systems.
  • Collaborate with global information security and privacy teams.
  • Create, maintain, and supervise IT&Q-compliant documentation including risk assessments and validation and operational documentation.
  • Support audits and inspections by providing complete documentation and compliance evidence.
  • Act as an advisor to Product Owners, architects, and engineering teams on IT&Q requirements.
  • Train and support teams on IT&Q processes, tools, and standards.
  • Promote use of IT&Q tools and ServiceNow solutions (ITSM, IRM, ITOM).
  • Support teams in using approved platforms (Pass List) and identify opportunities to simplify compliance processes by standardization.
Ework Group

Ework Group

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