Senior Business Systems Analyst, Quality Systems

KBI Biopharma, Inc. seeks a Senior Business Systems Analyst to support and improve regulated Quality Systems in a biopharmaceutical environment. The role partners with Quality, IT, and business stakeholders to ensure systems meet regulatory requirements and support business objectives.

Responsibilities:

• Lead requirements gathering, process mapping, and gap analysis for Quality Systems (e.g., eQMS, CAPA, Deviations, Change Management, Audit Management)
• Translate business and regulatory requirements into clear functional and technical specifications
• Partner with Quality and business operations to design compliant and efficient system solutions
• Ensure systems comply with GxP, 21 CFR Part 11, Annex 11, and data integrity principles (ALCOA+)
• Support system validation activities, including validation planning, risk assessments, IQ/OQ/PQ, and change control
• Act as a subject matter expert for Quality Systems during internal and external audits and inspections
• Own or support system lifecycle activities including implementation, upgrades, enhancements, and decommissioning
• Identify opportunities to streamline Quality processes through automation, standardization, and system integration
• Evaluate vendor solutions and support system selection activities
• Serve as a trusted advisor to Quality leadership on system capabilities and roadmap planning
• Lead cross-functional workshops and working groups
• Mentor junior analysts and contribute to best practices for business analysis and validation
• Support data governance, reporting, and analytics for Quality metrics and KPIs
• Manages complex, multi-region or multi-site Quality System initiatives
• Operates with a high degree of autonomy and minimal supervision
• Problems are typically non-routine, requiring judgment, regulatory knowledge, and stakeholder alignment

Requirements:

• Bachelor's degree in Information Systems, Engineering, Life Sciences, or related discipline
• 6–10 years of experience in business systems analysis, with at least 4–6 years supporting GxP-regulated Quality Systems in the pharmaceutical or biotechnology industry
• Proven experience with eQMS platforms (e.g., Veeva Vault QMS, TrackWise, MasterControl)
• Strong background in system validation and regulated Software Development Lifecycle methodologies
• Deep understanding of biopharmaceutical Quality processes and regulatory expectations
• Strong analytical, documentation, and problem-solving skills
• Ability to communicate complex technical and regulatory concepts to non-technical stakeholders
• Experience working in global, matrixed organizations
• Advanced degree or relevant certifications (e.g., CBAP, PMP, CSV, ITIL) preferred
• Experience with EtQ
• Experience with Computer Software Assurance (CSA)
• Familiarity with FDA 21 CFR Part 11, Annex 11, and global regulatory expectations