Senior Quality Systems Business Analyst (GxP)

KBI Biopharma, Inc.

Jacksonville (NC)

On-site

USD 110,000 - 160,000

Full time

35 hours ago

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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.