Senior Manager, GxP Audit Program Lead

POSITION OVERVIEW Bicara Therapeutics is seeking an Audit Program Lead to own the execution and continuous improvement of Bicara's clinical site, vendor qualification, and internal audit programs. This role requires expertise in the nuances of clinical site and vendor audits, along with the judgment to evaluate compliance risk, the communication skills to influence outcomes across internal and external stakeholders, and the independence to drive timely program execution. The ideal candidate operates as a trusted subject matter expert and program owner, anticipating program needs and keeping multiple concurrent audit workstreams on track with precision. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week. RESPONSIBILITIES - Responsible for ensuring the execution of the risk-based audit program, including the master audit schedule, annual audit schedules, qualification methodology, and requalification cadence across clinical site, supplier/vendor, and internal audit domains. - Lead end-to-end execution of clinical site and vendor audits, facilitate risk-based site selection, audit planning, agenda development, on-site/remote execution oversight, report finalization, and response resolution, and CAPA completion. - Apply understanding of GxP requirements and compliance risk factors to tailor audit scope and depth appropriately, and perform initial review of audit reports, observations, and responses. - Maintain a current, accurate qualified vendor list. - Track Quality Agreement status and revisions. - Lead end-to-end execution of internal audits assessing the state of process compliance; facilitate execution logistics, track findings through resolution, guide SMEs through root cause analysis and CAPA development. - Interpret and apply global regulations and guidance documents, assessing organizational compliance. - Support inspection readiness activities and regulatory agency inspections, by acting as a member of the Quality Inspection team, supporting hosting logistics, aide in readiness preparations and representing the audit program as a credible, well-prepared SME. - Manage contract auditors conducting audits, ensuring quality, consistency, and regulatory rigor in findings and reporting. - Manage relationships with contract auditors and external auditees, exercising strong influence and negotiation skills to resolve scheduling conflicts, and ensure scope & observation alignment. - Process CDAs, contracts, POs, and invoices for contract auditors; verify auditor qualifications prior to engagement. - Facilitate observation tracking and trending to identify potential compliance risks and systemic gaps across audit findings, communicate findings to Quality leadership. - Collaborate with QA counterparts to identify emerging risk areas and adjust audit priorities and scope accordingly. - Own audit program metrics and reporting to Quality Leadership, communicating status clearly and proactively. - Continuously refine audit processes, tools, and templates to improve program efficiency and audit quality. - Ensure audit records are maintained within Bicara's QMS (Veeva, Egnyte GxP) with high accuracy and are audit-ready at all times. - Review compliance documents, SOPs, and protocols as assigned. QUALIFICATIONS BASIC QUALIFICATIONS - BS degree in life sciences or related field. - 8+ years of experience in biotech/pharmaceutical including 5+ years in Quality Assurance, with significant hands-on audit coordination and execution experience, specifically in clinical site auditing. - Demonstrated ability to work autonomously, manage competing priorities, and drive audit program execution with minimal oversight. - Auditor certification (e.g., ASQ CQA, RAB, or equivalent) preferred. - Deep, practical understanding of the nuances and complexities of GxP audits, including working expertise in vendor/site- risk assessment, risk based qualification approaches, and audit responses. - Working knowledge of vendor qualification and internal auditing processes - Extensive knowledge of global GMP/GCP regulatory requirements (FDA, EU, ICH) and industry best practices. - Excellent written and verbal communication skills, with proven ability to influence stakeholders at multiple levels, internally and externally. - Exceptional organizational skills and high attention to detail and accuracy, with the ability to manage multiple concurrent audits without dropped details. - Strong critical thinking and pragmatic problem-solving skills; able to identify issues and independently propose solutions. - Up to 10% travel (domestic and international). PREFERRED QUALIFICATIONS - Additional accreditations/certifications in quality or auditing. - Experience training, mentoring, or managing auditors. - Direct experience hosting or supporting regulatory agency inspections. - Experience leading process improvement initiatives across a quality organization. - Proficiency with Veeva or similar compliance/QMS software. COMPANY OVERVIEW Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. For more information, please visit www.bicara.com http://www.bicara.com. Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply. Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.