Business Systems Analyst

  • Contract
  • Anywhere

Website Skill Inventions Inc.


  • 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 PHC 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 (GCP) environment
  • Business processes around financial controls and portfolio management of large scale engineering capital projects
  • Computer systems validation


Other comments:

Worker will be required to work onsite in South San Francisco 2-3 days per week

Top Skills: 1) Strong Business Systems Analyst and communication skills 2) Expert-level knowledge of GDPR, CCPA, HIPAA, SaMD, 21 CFR part 11, Article 11 etc 3) Ability to manage the compliance documentation processes and systems with limited supervision

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