- Review and approve Master Production Records and executed records from CMOs for Drug Substance and Drug Product operations.
- Perform final Product Disposition for clinical trials, extended access programs, and commercial supply.
- Provide Quality oversight for commercial packaging, distribution qualifications, validations, and serialization.
- Author and revise quality system SOPs and work instructions.
- Review and approve deviations, CAPA, change controls, and labeling/artwork for clinical and commercial products.
- Support inspection readiness, regulatory responses, and ongoing commercial process monitoring.
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