Senior IT Quality & Compliance Leader – Audit & Risk

FTINC Fortrea Inc.; North Carolina; On-site; USD 120,000 - 180,000; Full time

Job summary

Fortrea Inc. is seeking a Senior Manager, IT Quality and Compliance to lead IT audit support, risk assessment, and program management within a global quality framework. You will work with IT and business units, clients, sponsors, and inspectors to ensure timely responses and compliant documentation.

The role emphasizes cross-functional leadership, career development for staff, and alignment with statutory and industry best practices in IT quality and validation.

Qualifications

• 8+ years in audit/compliance with 5+ years IT/data management focus.
• Experience in CRO/clinical industry.
• Strong knowledge of audit processes and program management.
• Experience in heavily regulated environments (SOX or GxP).
• Familiar with regulatory requirements in pharma and drug development in USA, EU, APAC.
• Knowledgeable in validation methodologies (SDLC) in IT.

Responsibilities

• Lead internal business and IT partners in audits (client, regulatory, QA).
• Coordinate contract reviews, client questionnaires, and proposals affecting IT compliance.
• Be the point of contact for IT audit support and ensure adequate resourcing.
• Track planning and report audit support metrics for timely actions.
• Lead components of the IT Quality program globally.
• Represent IT Quality on global IT projects and governance committees.
• Guide business units on compliance with statutory requirements and ensure documentation.
• Triages IT Quality Events and ensures CAPA actions close on time.
• Recommend controls for computer systems to ensure data integrity and safety.

Skills

Audit experience

IT risk management

Regulatory compliance

Leadership

Client & stakeholder management

CRO/Clinical industry experience

SOX / GxP knowledge

SDLC validation

Job description

Fortrea Inc. is seeking a Senior Manager, IT Quality and Compliance to lead IT audit support, risk assessment, and program management within a global quality framework. You will work with IT and business units, clients, sponsors, and inspectors to ensure timely responses and compliant documentation.

The role emphasizes cross-functional leadership, career development for staff, and alignment with statutory and industry best practices in IT quality and validation.