Katalyst CRO
Overview
Join to apply for the CQV Lead, Compliance role at Katalyst CRO Responsibilities
Lead CQV compliance activities, ensuring adherence to FDA, cGMP, and internal quality standards. Provide oversight of commissioning, qualification, and validation deliverables across equipment, utilities, and facilities. Review and approve protocols, summary reports, deviations, and change controls. Collaborate with cross-functional teams (Engineering, QA, Manufacturing, IT) to drive compliance initiatives. Support audits and inspections by preparing documentation and responding to regulatory queries. Manage and track compliance-related activities using Maximo during system migration and steady-state operations. Train and mentor junior team members on CQV compliance requirements and best practices. Requirements
Bachelor\'s degree in engineering, Life Sciences, or a related field. 7+ years of experience in commissioning, qualification, and validation within the pharmaceutical/biotech industry. Strong knowledge of cGMP, FDA, and ICH guidelines. Experience with Maximo (preferred; strong plus if involved in system migrations). Excellent technical writing, documentation, and communication.
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Join to apply for the CQV Lead, Compliance role at Katalyst CRO Responsibilities
Lead CQV compliance activities, ensuring adherence to FDA, cGMP, and internal quality standards. Provide oversight of commissioning, qualification, and validation deliverables across equipment, utilities, and facilities. Review and approve protocols, summary reports, deviations, and change controls. Collaborate with cross-functional teams (Engineering, QA, Manufacturing, IT) to drive compliance initiatives. Support audits and inspections by preparing documentation and responding to regulatory queries. Manage and track compliance-related activities using Maximo during system migration and steady-state operations. Train and mentor junior team members on CQV compliance requirements and best practices. Requirements
Bachelor\'s degree in engineering, Life Sciences, or a related field. 7+ years of experience in commissioning, qualification, and validation within the pharmaceutical/biotech industry. Strong knowledge of cGMP, FDA, and ICH guidelines. Experience with Maximo (preferred; strong plus if involved in system migrations). Excellent technical writing, documentation, and communication.
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