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Bicara Therapeutics, a clinical-stage biotech company focused on bifunctional antibodies for targeted tumor modulation, seeks a Senior Manager to lead its GxP Audit Program. This role owns the execution and continuous improvement of clinical site, vendor qualification, and internal audit programs, requiring deep expertise in GxP compliance, audit methodology, and regulatory requirements.
Key responsibilities include: designing and executing a risk-based audit program across clinical sites, suppliers, and internal functions; leading end-to-end clinical site and vendor audits from planning through CAPA completion; maintaining qualified vendor lists and quality agreements; executing internal audits assessing process compliance; interpreting global regulations (FDA, EU, ICH) to assess organizational compliance; managing contract auditors and external relationships; tracking and trending audit observations to identify systemic compliance risks; supporting regulatory inspection readiness; and owning audit program metrics and reporting to Quality leadership.
The ideal candidate operates as a trusted subject matter expert and program owner, anticipating needs and managing multiple concurrent audit workstreams with precision. You will apply deep understanding of GxP requirements and compliance risk factors to tailor audit scope, perform initial review of audit reports, and guide root cause analysis and CAPA development. Strong communication and influence skills are essential for managing stakeholders internally and externally, resolving scheduling conflicts, and ensuring scope alignment.
This Boston-based role follows a hybrid schedule with three in-office days per week and includes up to 10% domestic and international travel.
