Director, IT Quality Compliance
Bicara Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Boston • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $210,000 - $240,000 per year
Job Level
Lead
Tech Stack
CloudSDLC
About the role
- 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.
Requirements
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
IT quality strategiescompliance strategiesrisk assessmentscomputer system validationSoftware Life Cycle (SLC) methodologyvalidation methodologiesregulatory complianceKPI reportingemerging technologiesstandardized tools for validation
Soft skills
leadershipcommunicationstakeholder engagementinterpersonal skillsproblem-solvingcollaborationorganizational skillscreativityrespect commandproject management
Certifications
Bachelor’s Degree