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IT Quality and Compliance Manager
1 miesiąc temu
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. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Fortrea is seeking a highly motivated and experienced IT Quality and Compliance Manager to join our team. The successful candidate will be responsible for IT validation activities, providing guidance for IT QC/validation initiatives for the business units they support, and liaising with IT Project Managers to execute the project-specific IT validation strategy.
The IT Quality and Compliance Manager will work closely with various stakeholders, including Sponsor Auditors, Internal Audit, QA, IT Operations, and other applicable areas, to provide oversight for project-specific IT Computer System Validation projects and manage IT validation aspects within a highly regulated environment.
The ideal candidate will have 8+ years of experience in a FDA (GxP) regulated industry, a Bachelor's Degree, and industry-related certifications. They will be a motivated problem-solver and creative thinker who shares our passion for overcoming barriers in clinical trials.
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.)
What We Offer:
Fortrea is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.
