Senior Manager, IT Quality and Compliance
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Job Description
Fortrea IT quality leader overseeing global audits, compliance, controls, and validation programs. Leading teams, audit support, regulatory readiness, CAPAs, and system validation across regulated environments.
Responsibilities:
- Assist the Director in executing, operationally managing, and measuring performance of IT global controls framework, program management, IT risk assessment, IT audit management, and M&A support
- Serve as the interface between Fortrea IT and clients, customers, study sponsors, and inspectors
- Work with IT groups to obtain answers to audit queries and ensure follow-up and timely completion of IT Quality events
- Facilitate and guide career growth and development of professional-level staff
- Lead internal business and IT partners in client, regulatory, and QA audits
- Coordinate, review, and complete contract reviews, client questionnaires, proposal requirements, and other IT compliance initiatives
- Serve as point of contact for IT audit support resources and ensure appropriate support levels
- Track, plan, and report audit support metrics to ensure appropriate resourcing
- Lead management and execution of components of the global IT Quality program
- Represent IT Quality on global IT projects and committees as a subject matter expert and provide compliance oversight
- Develop and maintain formal documentation, including policies, standards, and procedures, aligned with corporate, legal, regulatory, and industry best-practice requirements
- Represent IT quality interests in key IT Governance teams, including system validation, infrastructure controls, risk management, and policy compliance
- Triage Audit Quality Events and ensure appropriate IT ownership
- Monitor IT Quality Events and CAPAs, provide guidance, and ensure complete actions with on-time closure
- Recommend controls for computer systems to ensure application and infrastructure reliability, data integrity, and subject safety
- Deliver technology, standards, and processes aligned with department objectives and goals
- Partner with Corporate, QA, IT Client Engagement, and SLC functions to assess and leverage supplier information for validation activities
- Lead a team by articulating direction and expectations
- Coach and support direct reports in creating development plans and building leadership skills
- Educate and train IT staff, business associates, and IT Project Leads on IT Quality Compliance and validation methodology
- Create training materials and provide training opportunities on IT Quality, Compliance, and computer system validation across business units
Requirements:
- Minimum 8 years of experience working in an audit/compliance function, with 5 years focused on IT and/or Data Management
- Strong knowledge of the audit process, including preparation, performance, reporting, follow-up, and closure
- Experience with audit program management
- Prior experience in heavily regulated environments such as financial (SOX) or pharmaceutical (GxP) industries
- Knowledge of regulatory compliance requirements in pharmaceutical and drug development industries in the USA, EU, and APAC
- Familiarity with various validation methodologies (SDLC) and their implementation in an IT organization
- Experience working in a team-oriented, collaborative environment
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