Director, IT Quality Compliance

Position Overview

The Director, IT Quality Compliance provides strategic and regulatory compliance subject matter oversight and direction in deployment of the Bicara Quality Management System, resulting in substantial compliance with GxP and data integrity requirements. This role ensures IT systems and processes meet global regulatory requirements and internal standards, while fostering a culture of continuous improvement, risk awareness, and operational excellence. The role will report to the Senior Vice President, Quality Assurance.

This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

Responsibilities

• 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.

Qualifications

• Bachelor’s Degree required (ex. science based, operations research, technology, etc.)
• 10 years’ experience in an FDA (GXP) regulated industry (i.e. such as pharmaceutical, medical device, or biotechnology) including:
• 5 years’ experience leading/managing teams, developing strategies, execution of projects.
• 5 years leading large IT validation projects.
• Expert in various validation methodologies (SDLC), and their implementation in an IT organization.
• Knowledgeable of regulatory compliance requirements in the pharmaceutical and drug development industry (GxPs).
• Creative approach to resolving technical issues, and balancing IT and business needs.
• Strong interpersonal skills and ability to command respect of others.
• Ability to interact with all levels within the organization.
• Program & Project Management experience – ability to plan, organize, and execute work across multiple initiatives.

Company Overview

Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara’s lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn or X.

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.