P5
QUALIT1.QUALITYA4A7C.P5
Quality Assurance - Biotechnology CDMO (GxP/Regulated) — P5

JobFrame · QUALIT1.QUALITYA4A7C.P5

Quality Assurance · Quality Assurance - Biotechnology CDMO (GxP/Regulated)

P5 · P5 — Expert Professional

Median pay · United States

$138,423

$108,743$176,203 · USD · annual · national base (function pricing in review)

Median pay

$138,423

$108,743–$176,203

Level

P5

Super-function

technology

Demand-heat

very hot

3.5% growth

Summary

Quality Assurance for a biotechnology Contract Development and Manufacturing Organization (CDMO) operating in a GxP/regulated environment. Distinct from QC analytical testing focus (this is QA oversight of the quality system, not bench testing) and from in-house pharma QA in that it centers on CDMO-specific demands: client/sponsor quality interface, CMO oversight, quality agreements, batch disposition for multiple client products, and hosting client and regulatory inspections. Spans batch record review and disposition, deviation/investigation/CAPA/change control management, QMS ownership, supplier/CMO quality, and regulatory inspection readiness under cGxP, FDA, and ROW frameworks.

This level — P5 P5 — Expert Professional

Expert in field; key problem solver and project leader, authority in multiple areas

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