SVT COMPLIANCE LEAD

Job Overview This position is responsible for direct interaction with internal customers to determine hardware, software and system requirements.
Ensures SDLC, ASLM, FDA, and SOX compliance for IT Projects in every portfolio.
The position will define and analyze system needs\/problems; design and test standards and solutions, create SDLC documentation, and ensure validation documentation meets requirements *CV must be sent in English* Essential Functions Performs and oversees software project validation in line with departmental SOPs and guidelines.
Ensures SDLC validation documentation content is complete, maintained and meets GxP\/FDA requirements.
Authoring and\/or contributing to all validation deliverables including Plan, Requirements, Test Plan, Design, Protocols, Traceability Matrix, Baseline, Reports and Standard Operating Procedures (SOPs).
Assesses company's computer systems and identifies any potential GxP or FDA Part 11 gaps Participates in regulatory audits and provides information on validation activities performed for Q2 computer systems.
Providing standardized templates, guidance, and overall validation direction supporting various programs Reviews internal and external requirements and implements required processes as needed to meet expectations regarding Quality All other System Validation Team processes and tasks as needed Qualifications Bachelor's Degree in Computer Science, a related field or equivalent experience in a medical, clinical, pharmaceutical or analytical setting Over Five (5) years related experience in Software Validation in a medical, clinical, pharmaceutical or analytical setting Excellent communication skills in English Experience with FDA, GxP, Part 11 and SOX validation rules and regulations Ability to travel to Q2 Solutions sites for in-person audit support as required Desired Technical Abilities HP ALM HP Quality Center Jira Software Validation SDLC Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.
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