Manager, IT Quality and Compliance
1 tydzień temu
As a top contract research organization (CRO) worldwide with a strong focus on scientific excellence and extensive experience in clinical development, Fortrea offers a wide array of clinical development, patient access, and technology solutions in over 20 therapeutic areas to pharmaceutical, biotechnology, and medical device clients. With a workforce of over 19,000 employees operating in 90+ countries, Fortrea is revolutionizing drug and device development for partners and patients globally.
Reporting to the Senior Manager of IT Quality and Compliance, the Manager holds responsibility for IT validation tasks. The Manager will offer guidance on IT QC/validation initiatives for the supported business units, working closely with IT Project Managers to implement project-specific IT validation strategies and oversee computer systems validation activities.
In addition, the Manager will collaborate regularly with leaders from various areas such as Sponsor Auditors, Internal Audit, QA, IT Operations, and others. They will supervise project-specific IT Computer System Validation projects and handle IT validation components in a highly regulated setting.
The Manager will also support the Senior Manager in executing and managing IT global controls framework, program management, IT risk assessment, IT audit management, and M&A support. Acting as the face of Fortrea IT to clients, customers, study sponsors, and Inspectors, the Manager will work with different IT teams to resolve audit inquiries promptly and ensure timely resolution of IT Quality Events, primarily focused on audits in EU and Asia/Pac.
Responsibilities:
Assist with establishing, reviewing, executing, and ensuring compliance with regulatory requirements for Computer System Validation and infrastructure components qualification. Assist in implementing a standard SLC. Provide guidance on Computer System Validation strategy and document product functionality across system releases. Coordinate project-specific Computer System Validation efforts and test plan execution. Develop validation and test strategies for IT initiatives and present to project teams. Ensure timely completion of testing addressing user and functional requirements. Serve as the main contact for IT audit support resources and maintain appropriate support levels.Requirements:
8+ years of experience in an FDA (GxP) regulated industry like pharmaceuticals, medical devices, or biotechnology. Bachelor's Degree in relevant field (e.g. science, technology). Preferred industry certifications (e.g. PMP, CQE, CQM).Fortrea is in search of proactive problem-solvers and innovative individuals who share our drive to overcome challenges in clinical trials. Our firm dedication is to innovate the development process, ensuring prompt delivery of groundbreaking ideas and treatments to patients. Join our exceptional team and thrive in a collaborative environment where personal development is encouraged, allowing you to have a significant global impact.
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