Business Analyst with Release Management

Ascii Group, LLC is seeking a Business Analyst with expertise in Release Management and GMP Validation to support the Spark Integration project. This role focuses on developing validation strategies for QMS replacement and ensuring digital solutions comply with internal standards and GxP requirements.

Responsibilities:

• Develop and implement validation strategies for Spark Integration and QMS replacement
• Create validation plans, protocols, and reports for data-driven models and automation applications
• Conduct risk assessments for digital solutions used within GMP environments and develop mitigation strategies
• Partner with QA SMEs to align testing activities with Roche standards and document test findings
• Ensure all activities adhere to data integrity guidelines and GMP regulatory requirements
• Coordinate with IT Business Partners, Product Owners, Architects, and external vendors to harmonize business processes
• Manage Release Management processes and controls for business/end-user applications

Requirements:

• Project-based experience in the pharmaceutical industry (Technical Operations, Manufacturing, or Logistics)
• Strong knowledge of validation principles and practices in a GMP environment
• Understanding of SDLC models, Release Management controls, and test automation
• Ability to write technical validation documentation and explain complex concepts with clarity
• BE/BA degree; fluent in written and spoken English
• Prior experience with Veeva or patient/physician portals is a plus