Senior Quality Systems Analyst – GxP & Validation Expert

KBI Biopharma, Inc.; North Carolina; Hybrid; USD 110,000 - 160,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Senior Business Systems Analyst for Quality Systems to drive analysis, design, and implementation of regulated systems across Quality, IT, and business units. You will ensure compliance with FDA/EMA/ICH, enable scalable processes, and lead validation and data integrity initiatives.

The role requires deep GxP knowledge, strong stakeholder communication, and the ability to lead complex, multi-region projects with minimal supervision.

Qualifications

• Bachelor's degree in information systems, engineering, life sciences, or related field.
• Advanced certifications (CBAP, PMP, CSV, ITIL) preferred.
• 6–10 years in business systems analysis, 4–6 years in GxP-regulated Quality Systems.
• Experience with eQMS platforms (Veeva Vault QMS, TrackWise, MasterControl).
• Strong validation and regulatory SDLC knowledge; global regulatory familiarity.

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 operations to design compliant system solutions.
• Ensure compliance with GxP, 21 CFR Part 11, Annex 11, and data integrity (ALCOA+).
• Support validation activities including planning, IQ/OQ/PQ, risk assessments, and change control.
• Serve as SME during audits and inspections.

Skills

Requirements gathering

Process mapping

Gap analysis

Regulatory compliance

Stakeholder communication

Validation planning

Data integrity

Cross-functional collaboration

Education

Bachelor's degree

Advanced 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 drive analysis, design, and implementation of regulated systems across Quality, IT, and business units. You will ensure compliance with FDA/EMA/ICH, enable scalable processes, and lead validation and data integrity initiatives.

The role requires deep GxP knowledge, strong stakeholder communication, and the ability to lead complex, multi-region projects with minimal supervision.