Prilenia
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Biotech
Lead GCP quality for Prilenia's clinical programs from startup through inspection readiness. Oversee CRO and vendor QA, eTMF quality, CAPA resolution, audits, and regulatory inspection responses. Provide GVP and GLP QA oversight, author SOPs, define quality metrics, build a fit-for-purpose QMS, mentor QA staff, and represent QA in cross-functional governance.
