Bicara Therapeutics

Compliance

• Lead the development and execution of IT quality and compliance strategies aligned with enterprise risk and regulatory requirements.
• Oversee IT governance, risk assessments, and internal controls to ensure compliance with GxP, SOX, GDPR, and related regulations.
• Manage computer system validation activities, including initial validation, change control, and periodic reviews.
• Support internal and external audits, regulatory inspections, and RFI responses across global regions.
• Maintain and enhance the IT Quality Management System (QMS), including controlled documents such as policies, SOPs, work instructions, and templates.
• Co-own and manage the Software Life Cycle (SLC) methodology; provide training on SLC processes and deliverables.
• Define and report on KPIs related to IT compliance, risk, and audit readiness.
• Collaborate with all departments to ensure cross-functional compliance.
• Lead the development of a risk-based validation methodology and a harmonized Software Life Cycle (SLC) framework across IT systems.
• Define and tailor validation approaches for emerging technologies such as AI, cloud platforms, and advanced analytics, ensuring scalability and regulatory compliance.
• Implement standardized tools for computer systems validation to improve efficiency, reduce compliance costs, and protect company assets.
• Foster a culture of quality and accountability across IT and business teams through effective leadership, communication, and stakeholder engagement.

Director, IT Quality Compliance

Director

• Ensure that all clinical trial activities comply with GCP guidelines, international regulations (e.g., ICH-GCP), and applicable laws.
• Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements.
• Plan, conduct, and/or participate in internal audits and external inspections to assess GCP compliance and identify areas for improvement.
• Develop and deliver internal training programs on GCP principles, regulations, and best practices for relevant stakeholders
• Collaborate with cross-functional teams to identify potential internal or external risks to GCP compliance and develop mitigation strategies to address them effectively.
• Maintain and enhance Bicara Therapeutics’ QMS by implementing processes and procedures that ensure consistent adherence to GCP standards throughout the clinical trial lifecycle.
• Investigate deviations, non-compliances, and quality issues related to GCP and develop CAPAs to prevent recurrence and improve processes.
• Evaluate and monitor the performance of third-party vendors, including contract research organizations (CROs) to ensure compliance with GCP requirements.
• Drive continuous improvement initiatives to enhance the efficiency, effectiveness, and quality of GCP-related processes and procedures.

Director, IT Quality Compliance

Senior Director, GCP Quality Oversight