KBI: US - IT Business Systems Analyst

KBI Biopharma, Inc.; Jacksonville (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Senior Business Systems Analyst – Quality Systems to lead analysis, design, and continuous improvement of regulated business systems in a biopharmaceutical environment.

You will act as a liaison between Quality, IT, and business stakeholders to ensure compliance with global regulatory requirements. You will drive requirements, validation activities, risk assessments, and system lifecycle initiatives, focusing on FDA/EMA guidance, data integrity, and scalable

Qualifications

• Bachelor's degree or higher in a related field.
• Experience in GxP-regulated Quality Systems is required.
• Strong knowledge of FDA/EMA/ICH regulatory expectations.
• Proven experience with eQMS platforms.
• Experience with system validation and regulated SDLC methodologies.

Responsibilities

• Lead requirements gathering, process mapping, and gap analysis for Quality Systems (eQMS, CAPA, Deviations, Change Management, Audit Management).
• Translate business and regulatory requirements into clear functional and technical specifications.
• Partner with Quality and operations to design compliant, efficient system solutions.
• Ensure systems comply with GxP and data integrity principles (ALCOA+).
• Support validation activities including planning, IQ/OQ/PQ, and change control.
• Serve as SME for Quality Systems during audits and inspections.

Skills

Business analysis

Regulatory knowledge

GxP compliance

Documentation

Stakeholder communication

Education

Bachelor's degree in Information Systems, Engineering, Life Sciences

Advanced degree or certifications (CBAP, PMP, CSV, ITIL)

Tools

Veeva Vault QMS

TrackWise

MasterControl

Job description

The Senior Business Systems Analyst – Quality Systems is responsible for the analysis, design, implementation, and continuous improvement of regulated business systems supporting Quality operations within a biopharmaceutical environment. Operating as a senior individual contributor, this role serves as a key liaison between Quality, IT, and business stakeholders to ensure Quality Systems are compliant with global regulatory requirements (e.g., FDA, EMA, ICH), scalable, and aligned with business objectives.

Job 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.

Required Knowledge, Skills, & Abilities

• Bachelor’s degree in Information Systems, Engineering, Life Sciences, or related discipline.
• Advanced degree or relevant certifications (e.g., CBAP, PMP, CSV, ITIL) preferred.
• 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.

Desired Knowledge, Skills, & Abilities

• Experience with EtQ
• Experience with Computer Software Assurance (CSA)
• Familiarity with FDA 21 CFR Part 11, Annex 11, and global regulatory expectations.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.