Senior Business Analyst

We are seeking a highly experienced Senior Business Analyst with deep domain expertise in US pharmaceutical operations, drug manufacturing, and cell therapy lifecycle management within GxP-compliant environments . The ideal candidate will serve as a strategic bridge between business stakeholders and technology teams, driving digital transformation in regulated environments across MES, LIMS, QMS, ERP (SAP), and cloud platforms.

This role is critical to ensuring compliance with 21 CFR Part 11, GAMP5, and CSV (Computer System Validation) standards while enabling innovation in complex, patient-centric therapies such as cell and gene treatments.

Key Responsibilities

• Act as a primary liaison between manufacturing, quality, regulatory, R&D, supply chain, and digital health teams to gather, analyze, and translate business needs into actionable requirements.
• Lead end-to-end requirements elicitation through stakeholder interviews, workshops, surveys, and process mapping using BPMN, UML, and swimlane diagrams .
• Develop and maintain comprehensive documentation including:
• Business Requirements Document (BRD)
• Functional Requirements Document (FRD)
• User Requirement Specification (URS)
• Functional Requirements Specification (FRS)
• Traceability Matrix (from URS to test scripts)
• User Stories & Acceptance Criteria (Agile/Scrum)
• Data Mapping & Field-Level Specifications
• Map and validate drug manufacturing processes , including:
• Batch records
• Quality Control (QC) workflows
• Deviations, CAPA (Corrective and Preventive Actions)
• Serialization and product traceability
• Drive fit/gap analysis between current business processes and enterprise systems (e.g., SAP, MES, LIMS, QMS).
• Collaborate on validation deliverables under GxP and CSV frameworks:
• Develop URS, FRS, IQ/OQ/PQ test scripts
• Support creation of validation plans and execution of test cases
• Ensure alignment with 21 CFR Part 11 (electronic records/e-signatures) and GAMP5 guidelines
• Apply data modeling and analytics skills (SQL, Python) to support data integrity, process optimization, and validation testing.
• Contribute to cloud-based system implementations (AWS, Azure, or GCP) in regulated environments, ensuring compliance and scalability.
• Facilitate cross-functional collaboration across IT, Quality, Regulatory Affairs, and Manufacturing teams.
• Champion digital transformation initiatives with a focus on speed, agility, and patient-centric innovation .

Required Qualifications

• 12+ years of experience as a Business Analyst in regulated industries (pharma, biotech, medtech) .
• 5+ years of hands-on experience in US-based pharmaceutical operations or drug manufacturing , including cell therapy product development and commercialization .
• Proven experience working in GxP (Good Manufacturing Practice, Good Laboratory Practice, Good Clinical Practice) environments.
• Deep understanding of Computer System Validation (CSV) methodology, including:
• URS/FRS development
• IQ/OQ/PQ execution
• 21 CFR Part 11 compliance
• GAMP5 risk-based validation principles
• Expertise in end-to-end cell therapy lifecycle processes : from R&D and process development to manufacturing, release testing, and patient delivery.
• Strong proficiency in Agile/Scrum frameworks , with experience in creating user stories, acceptance criteria, and sprint planning.
• Advanced skills in process modeling (BPMN, UML) and documentation (Visio, Lucidchart, Confluence).
• Solid data analysis background: SQL, Python for data validation, traceability, and reporting.
• Experience with enterprise systems : SAP (especially ECC/ S/4HANA), MES, LIMS, QMS, ERP.
• Familiarity with cloud platforms : AWS, Azure, or GCP — particularly in regulated or hybrid environments.
• Excellent communication and facilitation skills with the ability to translate technical concepts for non-technical audiences.