IT Compliance Specialist

Overview
We are seeking a detail-oriented IT Compliance Specialist to ensure the organization’s technology systems and processes adhere to industry standards, internal policies, and regulatory requirements. This role involves providing technical support, managing computer systems, and maintaining IT infrastructure integrity. This resource will strengthen our regulatory, quality, and documentation compliance activities across multiple systems and business processes. This role plays an important part in ensuring our operations adhere to GxP expectations and regional regulatory standards (FDA and EMA). The ideal candidate is highly organized, detail-focused, and comfortable navigating cross-functional environments that involve IT, Quality, and operational teams.

Responsibilities

• Monitor and enforce compliance with IT policies, standards, and regulations across all departments.
• Assessing documentation, records, and related materials for completeness, consistency, and compliance with applicable GxP guidelines and global regulatory expectations.
• Partnering closely with business teams to review, refine, and execute change requests related to systems, processes, or data.
• Serving as a coordination point between IT, Quality, and business functions to drive compliance alignment across workflows and documentation systems.
• Assisting with data migration efforts, ensuring data quality, traceability, and integrity throughout the process.
• Identifying gaps or data integrity concerns and working with stakeholders to implement corrective actions that support inspection readiness.
• Ensuring that procedures, documentation, and system updates remain audit-ready in accordance with internal policies and external regulations.
• Supporting internal audits, health authority inspections, and continuous improvement initiatives as needed.

Qualifications

• Proven experience in IT support roles with a focus on compliance or security is preferred.
• Bachelor’s degree in Life Sciences, Engineering, Information Systems, or a related discipline.
• At least 2 years of experience working in a GxP-governed environment in compliance, quality, regulatory operations, or a similar function.
• Working knowledge of tools such as Veeva Vault, Box, IRT systems, ServiceNow, SAS, or comparable applications.
• Practical experience supporting data migration initiatives, with a strong grasp of data integrity principles and GxP documentation standards.
• Strong analytical thinking, attention to detail, and communication skills, with the ability to collaborate across technical and non-technical teams.
• Familiarity with change control processes, controlled document systems, and associated workflows within regulated environments.

This is a contract role, available under C2C or 1099 arrangements.

Pay: $50.00 - $65.00 per hour

Expected hours: No more than 40.0 per week

Work Location: Hybrid remote in Cambridge, MA 02142

Salary : $50 - $65