Systems Manager - GxP Compliance Systems at Soutec LLC | Torre
Systems Manager - GxP Compliance Systems
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Soutec LLC

Systems Manager - GxP Compliance Systems

Soutec LLC
Posted by
Valeria Caro
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You will ensure global GxP compliance, safeguarding critical systems for life sciences innovation.
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Full-time

Legal agreement: Contractor

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Remote (for Mexico residents)
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Posted 9 days ago

Requirements and responsibilities

Overview: - We are seeking an experienced Systems Manager - GxP Compliance Systems to oversee the governance, maintenance, and continuous improvement of regulated systems supporting GxP-compliant operations across the organization. - This role ensures that enterprise systems meet global regulatory requirements and internal compliance standards. Work Environment: - This is a fully remote, Full-Time Contractor position (12-month term) based in LATAM. Key Responsibilities: - Manage and maintain GxP-regulated systems supporting Quality, Manufacturing, Clinical, and Regulatory functions. - Ensure ongoing compliance with FDA, EMA, MHRA, and other global regulatory requirements. - Lead Computerized System Validation (CSV) activities, including validation planning, risk assessments, and IQ/OQ/PQ protocol execution. - Act as System Owner or Business System Manager, managing system configuration, user access, and role-based permissions. - Support internal audits, regulatory inspections, and address audit observations with CAPA development. Minimum Requirements: - Bachelor's degree in Life Sciences, Computer Science, Information Systems, or a related field. - 7+ years of experience in the pharmaceutical, biotechnology, or life sciences industry. - 5+ years managing GxP-regulated systems. - C1 English Level is required.
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