QUALIT1.QUALITYA4A7C.P3

Quality Assurance - Biotechnology CDMO (GxP/Regulated) — P3

JobFrame · QUALIT1.QUALITYA4A7C.P3

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

P3 · P3 — Mid-Level Professional

Median pay · United States

$82,468

$64,786 – $104,977 · USD · annual · national base (function pricing in review)

Median pay

$82,468

$64,786–$104,977

Level

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 — P3 P3 — Mid-Level Professional

Fully competent professional; works independently on standard projects

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