Quality Operation Manager (GMP) job opportunity at Sobi.

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Date2026-03-04T19:31:29.222Z bot
Sobi Quality Operation Manager (GMP)
Experience: General
Pattern: Full-time
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degreeGeneral
loacation San Diego, California, United States
loacation San Diego, Cal..........United States
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Job DescriptionThe Quality Operations Manager is responsible for supporting transition from legacy paper-based processes to a scalable and compliant Electronic Quality Management System (eQMS). This role ensures that the Quality System supports all stages of drug development — from nonclinical development through clinical development, regulatory submission (IND, NDA/BLA), commercialization, and product lifecycle management. The Quality Operations Manager will ensure compliance with applicable GxP requirements (GLP, GCP, GMP), applicable FDA and global regulatory expectations, and industry best practices.The position supports inspection readiness, regulatory submissions, vendor oversight, and efforts to foster a culture of quality and compliance across the organization.Key Responsibilities/Scope of the Job:eQMS TransitionAssess existing paper-based processes and develop a phased transition plan to electronic workflows.Ensure data integrity, Part 11 compliance (where applicable), and appropriate system validation.Support Integration of GXP processes across all GXP functional areas into a unified, risk-based framework.Quality System ManagementIntegrate or as appropriate, develop, implement, and maintain procedures for:Document controlTraining managementDeviations and nonconformancesCAPAChange controlRisk managementAudit managementComplaint handling (if applicable)Distribute and coordinate training of GXP proceduresSupport for External Quality Operation, if applicable Inspection Readiness & Regulatory Interface SupportInspection readiness programs across the organization.Regulatory agency inspections (e.g., FDA, EMA, other global authorities).Oversee timely and effective CAPA development and implementation in response to regulatory findings.Cross-Functional LeadershipCollaborate with Clinical, Regulatory, CMC, Nonclinical, IT and Commercial teams.Provide training and promote quality culture across the organization.Serve as a quality advisor to senior leadership.

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