IT&Q Compliance Manager
~35 - 39 EUR/ godz.B2B
MidFull-time·B2B
#384403·Dodano wczoraj·0
Źródło: nofluffjobs.comTech 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
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