IT Quality Lead (CSV)

Qualifications: - Providing the validation strategy for different computer systems in life sciences industry - Possess expertise in managing acquisitions and divestitures from a Computer System Validation (CSV) perspective. - Comprehensive understanding of the Computer System Validation process, particularly in relation to GxP applications and systems. - Capability to remediate CSV Validation documentation. - Strong understanding of CFR 21 Part 11 and the SDLC lifecycle related to validation requirements. - Ability to work within a team and independently. - Strong English communication and written skills required

Preferred Qualifications: - Previous experience working for an Innovative Medicine company is preferred. In addition to validation and regulation experience, the resource should have the following experience: - Project Leader/Senior 3-7 years of relevant experience - Work independently and guide/mentor Junior resource - Experience in the Pharmaceutical, biotechnology, or medical device industry - 2+ years' experience with System Development Lifecyle - 3+ years' experience in Computer System Validation (Based on the role selected) - Experience in FDA and/or global regulated environment with good understanding of GxP standards and Risk based validation - Knowledge of FDA guidance's and industry standards (i.e., GAMP) - Experience in writing and executing documentation for all aspects of the validation deliverables (etc. - requirements, compliance/validation plans, test protocols, test summary reports and compliance/validation reports) - Experience in reviewing system test and user acceptance test scripts, traceability matrix and design specs - Experience in QA Methodologies, designing, reviewing and approving test plans, systems and UAT test scripts and test procedures - Ability to work with remote teams and support several changes/projects simultaneously - Ability to provide validation guidance, timely reviews, and escalations to TQ management