Associate Director / Director IT Quality & Compliance

Job Description

JOB SUMMARY

Key responsibilities include

• Lead, develop and manage the Computer System Validation (CSV) team within IT, defining individual goals, learning paths and competencies aligned to the IT performance framework
• Operate a risk-based, CSA-ready validation programme aligned to GAMP 5 (2nd Edition) and FDA CSA guidance, applying critical thinking and risk-tiered scope so validation effort is proportionate to patient safety, data integrity and business impact.
• Implement, maintain and continually improve an Information Security Management System (ISMS) aligned to ISO/IEC 27001:2022 controls and integrated with the eQMS (MasterControl) for SOP advertisement, training compliance and document control, and with ISO 9001 quality management practices.
• Use the ITSM Configuration Management Database (CMDB) as the authoritative system inventory to drive governance decisions — criticality, GCP validation status, business and technical ownership, change approval workflow, dependencies and impact rating — across all regulated and corporate systems.

What you’ll need to succeed

• Bachelor’s degree in Information Technology, Computer Science, Engineering, Life Sciences or a related discipline; postgraduate qualification in quality, information security, regulatory affairs or business desirable.
• Minimum 10 years’ experience in the pharmaceutical, biotechnology, medical device or CRO industry, with at least 5 years leading a Computer System Validation, IT Quality, IT Compliance or IT GRC function in a GxP-regulated environment.
• Demonstrable expertise in GAMP 5 (2nd Edition), FDA Computer Software Assurance (CSA) guidance, 21 CFR Part 11, EU Annex 11 and ICH GCP E6 (R2/R3), with a proven record of moving an organisation from a prescriptive CSV model to a risk-based CSA approach.
• Hands on experience managing the ValGenesis platform (or equivalent validation lifecycle management system) as system owner and as the enterprise tool for CSV governance.
• Exposure to ISO/IEC 27001:2022, ISO 9001 and ISO 27701. Hands-on implementation, certification readiness and ongoing operation of an ISMS in a regulated organization is highly desired.

Are you interested in this position?

Apply by clicking on the “Apply Now” button below!

#PA2ASSISTRevolution
#GlobalAssistantConnect
#BusinessEmpowerment
#VirtualPAPlatform #SkillMatchmaking
#EfficientAssistance
#QualityServiceConnection
#SimplifyDelegateThrive
#PA2ASSISTImpact
#EmpoweringCollaboration