Senior IT Business Systems Analyst - Quality & GxP (Remote)

KBI Biopharma, Inc.; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Senior Business Systems Analyst for Quality Systems to design, implement, and continuously improve regulated systems supporting Quality operations.

You will collaborate with Quality, IT, and business stakeholders to ensure systems comply with FDA/EMA requirements, remain scalable, and align with business objectives. The role requires deep Quality process expertise, the ability to manage complex initiatives, and leadership in system optimization, validation

Qualifications

• 6–10 years of experience in business systems analysis with 4–6 years supporting GxP-regulated Quality Systems
• Experience with eQMS platforms and regulated SDLC is preferred

Responsibilities

• Lead requirements gathering, process mapping, and gap analysis for Quality Systems (eQMS, CAPA, Deviations, Change Management, Audit Management)
• Translate regulatory requirements into clear functional specifications
• Partner with Quality and business operations to design compliant and efficient system solutions
• Support validation activities including IQ/OQ/PQ and change control
• Interact as SME during audits and inspections and drive continuous improvement
• Mature data governance, reporting, and analytics for Quality metrics and KPIs

Skills

Quality Systems

Regulatory compliance

Business analysis

Communication

Validation

GxP

Audit readiness

Education

Bachelor’s degree in Information Systems/Engineering/Life Sciences

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

Tools

Veeva Vault QMS

TrackWise

MasterControl

EtQ

Job description

KBI Biopharma, Inc. is seeking a Senior Business Systems Analyst for Quality Systems to design, implement, and continuously improve regulated systems supporting Quality operations.

You will collaborate with Quality, IT, and business stakeholders to ensure systems comply with FDA/EMA requirements, remain scalable, and align with business objectives. The role requires deep Quality process expertise, the ability to manage complex initiatives, and leadership in system optimization, validation