Director, IT Quality Compliance

Role Summary

The Director, IT Quality Compliance provides strategic and regulatory compliance oversight in the deployment of the Bicara Quality Management System, ensuring 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 reports to the Senior Vice President, Quality Assurance. This role is based in the Boston office with a hybrid schedule (three in-office days per 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 (e.g., science-based, operations research, technology, etc.).
• 10+ years’ experience in an FDA (GXP) regulated industry (e.g., pharmaceutical, medical device, or biotechnology) including:
• 5+ years’ experience leading/managing teams, developing strategies, and executing 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.