Overview
On Site
Full Time
Skills
Computerized System Validation
IT Risk Management
FOCUS
GxP
Internal Control
Waterfall
Agile
Software Development Methodology
SAP ERP
Test Management
Change Control
Document Management
Quality Management
Corrective And Preventive Action
Management
IT Risk
Regulatory Compliance
Life Sciences
Cloud Computing
IT Strategy
Job Details
Roles & Responsibilities:
- Experience designing, implementing, and operating IT risk management, IT quality and IT compliance activities in a life sciences organization, with particular focus on GxP, IT internal controls, SDLC management.
- Experience designing, implementing, and navigating waterfall and agile SDLC (System Development Life Cycle).
- Experience in SAP/ERP Validation and test management.
- Experience leading IT risk, IT quality and IT compliance transformational programs.
- Experience in executing Change Control, and Document management.
- Experience with IT Quality Management Systems and CAPA management systems.
- Experience designing IT risk, IT quality and IT compliance operating models.
- Experience designing and implementing IT quality and compliance life sciences controls for cloud products.
- General IT strategy experience.
- Knowledge of IT systems, applications and tools required.
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