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Senior Manager, GxP Audit Program Lead at bicara-therapeutics

Department: Development

Compensation

$167,000 – $197,000/yr

Setup
Hybrid
Location
Boston, Massachusetts
Type
Full-time
Level
lead/mgmt
Posted

Description

Bicara Therapeutics is hiring an Audit Program Lead to own and continuously improve its clinical site, vendor qualification, and internal audit programs. The role leads risk-based audit planning and execution, audit reporting and CAPA resolution, vendor and internal audit oversight, inspection readiness, contract auditor management, compliance risk tracking, and audit program metrics. It is based in the Boston office on a hybrid schedule with three in-office days per week and requires a life sciences or related bachelor's degree, at least eight years of biotech or pharmaceutical experience including five years in Quality Assurance, and significant clinical site audit experience.

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