The opportunity: Independently manage end-to-end business analysis workstreams, mentor junior/intermediate BAs, and drive root-cause analysis to deliver clear requirements. Facilitate alignment across Legal, Quality Assurance, Software Engineering, and Validation to establish unified compliance goals. Map and evaluate multi-modal R&D workflows (As-Is vs To-Be) and translate the failure modes of automated pipelines into business impact assessments. Evaluate platforms against 21 CFR Part 11 and GxP standards, applying ALCOA+ principles to current and future data lifecycles, while conducting gap analyses on internal and third-party software.

Audit Trail Design & Privacy: Define requirements for robust, immutable audit trails and collaborate with Data Protection Officers to assess GDPR and HIPAA considerations, including participation in data protection impact assessments as appropriate. Strategy & Scope: Deliver impact across products or initiatives, translating requirements into strategic implementation plans and contributing to long-term roadmaps.

Who you are: Bachelor’s degree in Computer Science, Information Technology, Legal Studies, or a related field; 5+ years of Business Analysis or Consultancy experience, with at least 3+ years in life sci

The opportunity: Independently manage end-to-end business analysis workstreams, mentor junior/intermediate BAs, and drive root-cause analysis to deliver clear requirements. Facilitate alignment across Legal, Quality Assurance, Software Engineering, and Validation to establish unified compliance goals. Map and evaluate multi-modal R&D workflows (As-Is vs To-Be) and translate the failure modes of automated pipelines into business impact assessments. Evaluate platforms against 21 CFR Part 11 and GxP standards, applying ALCOA+ principles to current and future data lifecycles, while conducting gap analyses on internal and third-party software.

Audit Trail Design & Privacy: Define requirements for robust, immutable audit trails and collaborate with Data Protection Officers to assess GDPR and HIPAA considerations, including participation in data protection impact assessments as appropriate. Strategy & Scope: Deliver impact across products or initiatives, translating requirements into strategic implementation plans and contributing to long-term roadmaps.

Who you are: Bachelor’s degree in Computer Science, Information Technology, Legal Studies, or a related field; 5+ years of Business Analysis or Consultancy experience, with at least 3+ years in life sci