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Software Validation Quality Manager, Lifesciences

Location: United States,
Reference ID:

Our client is a global leader in providing sterilization solutions across multiple industries including Medtech, Pharma, Food, and Tissue with 90+ years of success and growth.  SSI has helped 10 people join this client since last year and we are now partnering with them for a Quality Manager for Software Validation as the incumbent is retiring.  This position will be responsible for overseeing all software validation activities for global regulatory compliance and act as the SME for software validation, systems development, installation, and operations oversight relevant to 21 CFR, ISO, EudraLex Volume Chapter 11, and GAMP 5 requirements.

The Right Talent:

BS Degree 

5+ Years of experience with computer systems validation in Medtech, Pharma, or a highly regulated industry

Knowledge and experience with SDLC, GAMP 5, GxP, and ISO standards

Experience writing software validation documents, user acceptance testing, and working with business processes

Strong experience leading projects and collaborating with sites

Experience auditing external auditors for computer-related supplies a plus





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