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Senior Business Analyst - IT Compliance and Infrastructure Qualification

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Date: Jul 1, 2019

Location: IN

Company: Cytel Inc

Cytel is looking for an experienced IT compliance and infrastructure qualification analyst to join the corporate IT team. This person will work closely with our IT infrastructure and QA teams to support our GxP Quality standards, regulatory requirements, and IT operational procedures and controls.


We will use a risk-based approach to ensure IT Infrastructure meets standards and regulatory requirements. This includes internally hosted, managed infrastructure, as well as external infrastructure such as SaaS and PaaS. This will be done using GDP, SOPs, work instructions, controls, internal audits, 3rd party audits and staff training, and operational controls. This position will also drive the creation of change control, deviation and CAPA records as needed to fulfill the compliance goals.

Essential Job Functions:

  • Function as Qualification Lead on multiple assigned infrastructure projects for hardware replacements, upgrades, patches and/or modifications to IT infrastructure needed to support quality systems and other enterprise applications. Projects may include IaaS, PaaS, virtualization, and datacenter qualifications.
  • Participate in the development and manage deliverables for the qualification aspects of the project, using risk-based approach to determine testing, documentation, and verification activities, with appropriate justification of the approach.
  • As necessary, modify/create Qualification Plan, Protocols, and Test Plans, Risk / security Assessments, Reports, Trace Matrix and SOPs.
  • Manage qualification testing coordinating documentation and testing activities. Generate test scripts, as needed. Execute testing as required
  • Participate in and guide team in generating, modifying, and defining configuration specifications, infrastructure landscape, and network diagrams.
  • Ensure qualification processes are executed as defined by company policy and procedures.
  • Support infrastructure change management processes and controls.
  • Develop Standard Operating Procedures (SOPs), work instructions, forms and other Infrastructure and commissioning deliverables to support the overall infrastructure project.
  • Manage electronic routing of required documentation ensuring compliance to current procedures for electronic document management.
  • Communicate status, solutions, and concerns. Disseminate information in a timely manner within the team. Facilitate and address issues within project.
  • Collaborate with vendor(s), quality, and technical individuals throughout project in generation of project / qualification required deliverables.
  • Collaborate with company Quality and Compliance unit staffs to ensure Infrastructure qualification projects are delivered on time and compliant to company and industry best practices.


  • Experience with SOP authoring relative to IT Infrastructure processes and applications.
  • Excellent verbal and written communication skills.
  • Ability to organize and present ideas in a convincing and compelling manner.
  • Ability to troubleshoot issues and work independently with minimal direction.
  • Self-motivated with high degree of initiative and excellent follow-up skills, along with strong analytical and problem-solving skills.

Technical Skills:

  • Knowledge of procedures and best practices related to FDA, EMA, GxP, CFR21 Part 11, Computer System Validation, GAMP and other regulations affecting IT Infrastructure security and compliance.
  • Knowledge of SOX, HIPPA, ITIL, and CIS Top 20 Security frameworks a plus
  • Microsoft SharePoint, Project, Office Tools


  • 7-10 years minimum experience in the Information Technology field.
  • 5+ years of working in Bio-Tech/Bio-Pharmaceutical Industry supporting IT Infrastructure Qualification projects.


  • Bachelor's Degree in Business Administration or Computer Science

Job Segment: Developer, CAPA, Information Systems, ERP, Quality, Technology, Management

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