Senior Manager, IT Quality and Compliance

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

💻 IT Support

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• 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