Lead - Biomanufacturing Compliance - Investigator, Deviations

Catalent

Lead compliance investigator for biomanufacturing operations at a GMP biologics facility. Responsible for authoring deviation records, managing investigations, and ensuring cGMP compliance across manufacturing processes. Collaborates with quality and manufacturing teams on corrective actions and inspection readiness.

Responsibilities

Author and revise deviation records, preventative actions, and related cGMP documentation
Track and monitor investigation status, providing timely updates to stakeholders
Lead compliance culture improvement initiatives and cGMP training efforts
Organize and lead inspection readiness activities and associated teams
Support internal and client audits regarding deviations and corrective/preventive actions

Requirements

High school diploma/GED plus 7+ years related experience, or Associate's in STEM plus 6+ years
3+ years experience with Bachelor's in STEM, or MS/PhD in technical discipline
Demonstrated expertise in deviation writing, root cause analysis, and CAPA implementation
Proficiency in Microsoft Office and quality systems like TrackWise, ComplianceWire, JD Edwards, Unicorn
Strong knowledge of cGMP principles and manufacturing/laboratory operations
Experience authoring, revising SOPs and technical documentation
Ability to read, write, and communicate clearly in English

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Vacancy posted 2 days ago

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