Senior Business Analyst - Pharmaceutical Manufacturing

CapgeminiBurlington, NY
10hHybrid

About The Position

Join Capgemini as a Senior Business Analyst to drive business outcomes for a new initiative to enable compliant, high-quality experimentation. As a partner to product management, engineering, data, QA, compliance, and vendor teams, this role will translate complex scientific and operational needs into clear requirements, orchestrate end-to-end process and data design, and ensure value realization from a COTS/SaaS platform in a regulated environment. The ideal candidate brings deep business analysis expertise across life sciences/CMC workflows, strong experience with commercial platforms, and fluency working in SAFe/Agile-at-scale programs.

Requirements

  • 5+ years of documented experience in a business analyst or PMO role in pharmaceutical or life sciences organizations.
  • Hands-on experience implementing or working with commercial (COTS/SaaS) platforms—ideally in laboratory, bioprocess, or experimentation domains.
  • Demonstrated delivery within regulated environments with QA/compliance collaboration.
  • Practical experience working in SAFe/Agile-at-scale programs
  • Familiarity with validation, data integrity, and GxP considerations for SaaS/COTS implementations.
  • Strong understanding of CMC/life sciences workflows and associated data/process needs.
  • Excellent stakeholder management, facilitation, and communication skills.

Responsibilities

  • Partner with product/program management, engineering, data, QA, compliance, and vendor teams to gather and clarify business, scientific, and operational needs.
  • Translate complex CMC/experimentation workflows into clear, testable functional and non-functional requirements and user stories.
  • Define data models, interfaces, and information flows needed to enable compliant, high-quality experimentation.
  • Lead/coordinate implementation of new COTS and SaaS solutions aligned to regulatory requirements.
  • Configure capabilities, define integrations, and align platform features to business outcomes.
  • Establish success metrics/KPIs and ensure value realization from the platform and workflows.
  • Support backlog prioritization, release planning, and readiness (incl. change management and training inputs).
  • Ensure processes and requirements align with applicable GxP/QA and data integrity expectations.
  • Partner with QA/compliance to embed controls, auditability, and validation considerations.
  • Leverage SAFe methodology and ceremonies (PI planning, backlog refinement, sprint reviews), and maintain high-quality artifacts (epics/features/stories, acceptance criteria) to support User Acceptance Testing.
  • Coordinate with vendors on solution design, issues, and roadmap alignment.
  • Communicate status, risks, and decisions to cross-functional stakeholders.

Benefits

  • Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave
  • Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
  • Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
  • Life and disability insurance
  • Employee assistance programs
  • Other benefits as provided by local policy and eligibility
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