Global IT Quality & Compliance Leader - Audit & Risk

Fortrea; Durham (NC); On-site; USD 120,000 - 170,000; Full time

Job summary

Fortrea is seeking a Senior Manager, IT Quality and Compliance to join the Global IT Q&C leadership team. You will assist the Director in executing and managing IT controls, risk assessment, audit management and M&A support across the organization.

You will lead audits, coordinate compliance initiatives, and guide staff growth while ensuring on-time completion of IT quality events and proper IT governance representation.

Qualifications

• 8 years experience in audit/compliance, 5 years focused on IT/Data Management.
• Experience in CRO/Clinical Industry.
• Strong knowledge of the audit process and audit program management.
• Prior experience in heavily regulated environments (SOX or GxP).
• Knowledge of regulatory requirements in pharmaceutical and drug development industries in USA, EU and APAC.
• Familiar with validation methodologies (SDLC) in an IT organization.
• Team-oriented, collaborative environment.

Responsibilities

• Lead internal business and IT partners in audits (client, regulatory, and QA).
• Coordinate contract reviews, client questionnaires, requirements for proposals, and other compliance initiatives affecting IT.
• Be the point of contact for IT audit support resources and ensure appropriate levels.
• Track, plan and report audit support metrics for resourcing.
• Lead components of the IT Quality program globally.
• Represent IT Quality on global IT projects and committees; provide oversight to guide units on compliance.
• Represent IT quality in IT Governance teams (system validation, controls, risk, policy compliance).
• Triage Audit Quality Events to ensure IT ownership.
• Monitor IT QEs and CAPAs; guide owners to complete actions on time.
• Recommend proper controls for computer systems to ensure reliability and data integrity.

Skills

Audit processes

IT compliance

Regulatory knowledge

Team leadership

Stakeholder management

Job description

Fortrea is seeking a Senior Manager, IT Quality and Compliance to join the Global IT Q&C leadership team. You will assist the Director in executing and managing IT controls, risk assessment, audit management and M&A support across the organization.

You will lead audits, coordinate compliance initiatives, and guide staff growth while ensuring on-time completion of IT quality events and proper IT governance representation.