Sr. Business Analyst ? GXP, GDP

Key Responsibilities:

• Analyze business user needs for applications/systems by examining business objectives, identifying key functional and non-functional requirements, and assessing the influence of those requirements on application/system behavior.
• Support Product Manager and Business Owner in managing application communication and stakeholder engagement
• Review applications for alignment with business goals, usability standards, and expectation management.
• Maintain comprehensive project and process documentation in alignment with defined requirements, contractual obligations, and organizational goals.
• Collaborate with quality teams to ensure adherence to standard operating procedures (SOPs) and compliance with regulatory policies.
• Author comprehensive user stories that encapsulate end-user perspectives and articulate clear, testable functional descriptions for system testing, and concise, relevant and testable acceptance criteria for user acceptance testing.
• Review and validate test scripts (functional and UAT) to confirm thorough coverage of documented requirements.
• Participate in user acceptance testing (UAT), supporting business users with test case execution and logging defects in tools such as Client ALM or q-Test.
• Coordinate with cross-functional teams to ensure all documentation, including test scripts, meets GDP (Good Documentation Practice) standards and industry best practices.
• Conduct hands-on testing in lower environments to identify defects, trouble shoot issues and recommend pre-deployment enhancements and fixes, respectively.
• Assist IT Project Manager to develop and maintain release timelines, integrating knowledge of team activities and dependencies into a cohesive, structured project schedule.
• Regularly report to and take direction from the Product Manager, escalate critical risks and findings, and assists in decision making processes and problem resolution
• Collaborate with Product Owners and Business Subject Matter Experts (SMEs) to communicate progress, resolve analysis blockers, and clarify ambiguous requirements.

• Demonstrated experience in business analysis for application/systems projects: requirements gathering, functional and non-functional requirements, process and impact analysis.
• Proven ability to translate business objectives into detailed, actionable technical documentation for development and testing.
• Strong experience with the software development life cycle (SDLC) including requirements analysis, design validation, integration, UAT, and deployment.
• Skilled in drafting detailed user story descriptions and acceptance criteria reflecting end-user needs and ready for testing.
• Experience working with project management and defect tracking tools (e.g., JIRA, Client ALM, q-Test, Confluence).
• Familiarity with maintaining project and process documentation in line with regulatory and organizational standards (GDP, SOP).
• Strong testing skills, including the review and creation of functional/UAT test scripts and execution of hands-on testing in non-production environments.
• Effective stakeholder engagement and communication, including the management of blockers, facilitation of meetings, and delivery of project updates to varying audiences.

• Bachelor's degree in Business Administration, Information Systems, Computer Science, or related field (Master's degree preferred)
• 6+ years of experience in business analysis or a related discipline within healthcare, biotech or similar regulated environments
• Professional certifications are an advantage (e.g., CBAP, PMI-PBA, Agile/Scrum certifications)
• Solid understanding of GxP and other relevant compliance standards
• Exceptional analytical, problem-solving, and organizational skills
• Excellent written and verbal communication abilities
• Experience working with globally distributed teams is a plus

• Highly detail-oriented and committed to documentation quality
• Strong team player adept at cross-functional collaboration
• Proactive, resourceful, and able to work independently
• Adaptable and comfortable working in a fast-paced, evolving environment
• Customer-focused, with a relentless commitment to improving business outcomes