Job Summary:
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We are seeking a highly skilled IT Compliance Expert to join our team. This role involves supporting the compliance of GxP systems and processes, collaborating with business stakeholders, and providing compliant business solutions.
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Main Responsibilities:
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1. Supporting the selection, development, validation, and maintenance of enterprise GxP systems, including Veeva, ServiceNow, Tracelink, Box GxP, SAS, PleaseReview, Veeva RIMS, DocuBridge, and supporting infrastructure.
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2. Collaborating closely with business colleagues to define and document critical business processes and requirements.
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3. Prioritizing requests, creating compelling business cases for technology solutions, and guiding them through the IT governance process.
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4. Driving the planning, implementation, validation, and support of enterprise GxP applications.
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5. GxP System Operations:
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6. Overseeing application lifecycles for enterprise GxP IT systems, collaborating with business partners, to ensure effective change control, testing, validation, and communication.
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7. Acting as a subject matter expert for the IT GxP Compliance Program.
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8. Partnering with QA to manage systems validation, periodic reviews, and vendor coordination.
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9. Leading or supporting deviation/incident investigations related to corporate GxP information systems and managing the implementation of identified Corrective Actions/Preventive Actions (CAPA) resulting from these investigations.
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10. Supporting as needed in external/internal audits and inspections.
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11. Responsible for managing changes to IT GxP systems and supporting processes.
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* Technical Requirements:
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o IT biotech project management experience in a multinational environment.
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o Deep understanding of biotech/pharmaceutical manufacturing systems and processes supporting drug safety, pharmacovigilance, manufacturing, engineering automation, regulatory compliance, quality management, and medical information, or clinical trials applications.
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o Knowledge of systems software, operations, capacity management, mid-range servers, PCs, SAAS, and web services.
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o Hands-on experience in qualifying production servers to meet regulatory requirements.
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o Expertise with Software as a Service (SaaS) systems, automated process equipment, and clinical data management software in the biotechnology or pharmaceutical industry.
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o Experience with Veeva RIMS, QMS, QDocs, SAS, PleaseReview, LabVantage LIMS, ServiceNow, DocuSign Part 11, Clinical Data Repository, Electronic Notebooks solutions highly desirable.
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o Risk assessments, remediation plans, and corrective and preventive action (CAPA), and reviewing, modifying, and writing standard operating procedures (SOPs).
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o Solid applied knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, and GAMP 5, CSA, Data Integrity.
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o Managing change control processes.
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o Excellent communication skills with the proven ability to interface and influence at all levels in the organization.
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o Detailed-oriented with strong analytical, organizational, and problem-solving skills.
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o Ability to troubleshoot, research, and solve technically challenging problems involving integrated systems.
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o Strong customer service orientation and an understanding of business processes related to pharmaceutical and dietary supplement manufacturing.
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o Occasional travel required, as needed.
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Benefits:
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This role offers a competitive total rewards package, which includes a 401k with company match, healthcare coverage, and a broad range of other benefits.
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Required Qualifications:
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Bachelor's degree in Computer Science, Information Technology, or equivalent work experience.
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7+ years of experience supporting enterprise GxP IT systems.
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