IT Compliance Expert - GxP

As an IT system owner, your primary responsibilities will revolve around supporting IT compliance of GxP systems and processes, partnering with business stakeholders to maintain validated GxP systems, and providing compliant business solutions.

Requirements

• BS degree in computer science, information technology, or equivalent work experience.
• 7+ years of experience supporting enterprise GxP IT systems, with experience in the following:
• IT biotech project management experience in a multinational environment.
• Deep understanding of biotech/pharmaceutical manufacturing systems and processes supporting drug safety, pharmacovigilance, manufacturing, engineering automation, regulatory compliance, quality management and compliance, medical information, or clinical trials applications.
• IT working knowledge in a biotech research lab environment, familiar with lab systems implementation and system requirements, clinical operations.
• Knowledge of systems software, operations, capacity management, mid-range servers, PCs, SAAS, and web services. Must have hands-on experience in qualifying production servers to meet regulatory requirements.
• Knowledge and expertise with Software as a Service (SaaS) systems, automated process equipment, and clinical data management software in the biotechnology or pharmaceutical industry.
• Experience with Veeva RIMS, QMS, QDocs, SAS, PleaseReview, LabVantage LIMS, ServiceNow, DocuSign Part 11, Clinical Data Repository, Electronic Notebooks solutions highly desirable.

Benefits

• performance-based incentives
• competitive total rewards package
• 401k with company match
• healthcare coverage