Business Systems Analyst - validation, GxP, FDA 21 CFR part 11, HIPAA, SaMD & ISO 13485, Data Privacy *** Direct end client *** Hybrid model

Depends on Experience

Contract: W2, Corp-To-Corp, Independent, 12 Month(s)

  • Work from home
  • No Travel Required


Business processBusiness analysisCross-functionalData managementWorkflowProject managementProcess flowProcess modelingImplementationGxP

Job Description

Your specific responsibilities will include:

  • Concurrently manage multiple projects of diverse scope across functional areas

  • Manage and deliver projects using agile and waterfall methodologies

  • Manage project budgets, scheduling, planning and contractor resource assignment and track vendor and consultant performance including billing against budget and contract

  • Collaborate with Product Managers, Architects, Engineers, Developers, and User Experience Designers on scope, solutions, constraints, and risks.

  • Manage compliance documentation processes and systems for department and business partners

  • Characterize for compliance purposes as-built and vendor provided business solutions that may involve automated systems and/or modifications to business processes.

  • Provide expertise in documenting the deployment of systems and/or processes.

  • Perform a key role – as part of a project team in delivery of solutions that are cost effective, sustainable, and meet business requirements.

  • Be accountable for documentation, which may include, but is not limited to:

  • System Risk Assessments

  • Data Classification Reports

  • User Requirements

  • Validation Plans

  • Validation Reports

  • Validation Registries

  • Requirements Traceability Matrices

  • Test Plans

  • Test Reports

  • Functional and/or technical specifications

  • Data and process flow diagrams

  • Training documentation and/or work instructions

  • Other Computer System Validation documents and related systems

  • Depending on the application configure system settings and/or options.

  • Provide consultation to customers regarding enhancement/improvement of current solutions and implementation of new solutions – both systems and processes.

  • Facilitate and/or support customers in UAT planning and execution.

  • Participate in and advise roadmap discussions; be a key member of vendor assessment teams.

  • Drive resolution of business or systems issues.

  • Be a trusted partner for the Global Privacy Office, IT Security, and Business Quality teams

  • Maintain an expert-level knowledge of the dynamic health authority governance; inclusive of GDPR, CCPA, HIPAA, SaMD, 21 CFR part 11, Article 11.


Experience Profile:

  • BA or BS in life science, informatics, business, or equivalent. MA or MS and post-graduate coursework are desirable. 

  • At least 10 years of related experience, domain knowledge of the pharmaceutical industry and manufacturing/quality assurance processes and systems, computer systems validation, GxP, FDA 21 CFR part 11, HIPAA, SaMD & ISO 13485, Data Privacy 

  • Experience and understanding of application development methodology - including Agile and Waterfall approaches, functional requirements, process modeling and re-engineering, use case development, user acceptance testing, organizational change management, and large-scale system implementations.

  • Excellent written and verbal communication skills; able to quickly produce clearly written, well-organized documentation; excellent presentation and meeting facilitation skills.

  • Proven skills in relationship building, customer-focus, decision-making, and problem solving.

  • Demonstrated ability to quickly learn the business in unfamiliar areas.

  • Experience with and understanding of any of the following areas a plus:

  • Pharmaceutical/Biotech Good Clinical Practice (Google Cloud Platform) environment

  • Business processes around financial controls and portfolio management of large scale engineering capital projects

  • Computer systems validation