Manager, IT Quality and Compliance

4 tygodni temu

Warsaw, Polska POL Fortrea Poland Sp z o.o. Pełny etat

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Reporting to the Senior Manager of IT Quality and Compliance, the Manager is accountable for IT validation activities. The Manager will provide guidance for IT QC/validation initiatives for the business units that they support. The Manager will liaise with IT Project Managers to execute the project-specific IT validation strategy by coordinating and guiding computer systems validation activities.

The Manager will also work regularly with respective leaders from Sponsor Auditors, Internal Audit, QA, IT Operations, and other applicable areas. The Manager will provide oversight for project-specific IT Computer System Validation projects and manage IT validation aspects within a highly regulated environment.

The Manager is also responsible for assisting the Senior Manager in the execution, operational management, and performance of one or more of the disciplines of the IT global controls framework, program management, IT risk assessment, IT audit management and M&A support. The Manager is the interface of Fortrea IT to our clients, customers, study sponsors and Inspectors. As the interface, you will also work with the various IT groups to obtain answers to audit queries and to ensure proper follow-up and on-time completion to IT Quality Events. Primarily supporting audits in EU and Asia/Pac.

Responsibilities:

Assist with establishing, reviewing, executing, and ensuring compliance with governmental regulatory requirements, policies, standards, and procedures related to processes for Computer System Validation and qualification of infrastructure components. Assist with the implementation of a common SLC. Advise the project team on and be responsible for Computer System Validation strategy and documentation of product functionality across system releases. Coordinate project-specific Computer System Validation efforts, including coordination of the execution of the test plan. Prepare validation and test strategies for IT initiatives, and present to project teams. Ensure that the testing is completed on time and that it addresses all user and functional requirements as defined during the requirement definition process. Point of contact for IT audit support resources and ensure appropriate IT audit support levels.

Requirements:

8+ years experience in a FDA (GxP) regulated industry (i.e. such as pharmaceutical, medical device, or biotechnology) Bachelor’s Degree required (ex. science, technology, etc.) Industry related certifications preferred (e.g. PMP, CQE, CQM, etc.)

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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