Senior Quality Systems Analyst - GxP IT

KBI Biopharma, Inc.; United States; Remote; USD 120,000 - 165,000; Full time

Job summary

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

The role requires deep expertise in Quality processes, independence in delivering complex initiatives, and leadership in system optimization, validation strategy, and data integrity, across global sites and functions.

Qualifications

• Bachelor’s degree in Information Systems, Engineering, Life Sciences, or related discipline.
• 6–10 years of experience in business systems analysis, including 4–6 years with GxP-regulated Quality Systems.
• Experience with eQMS platforms such as Veeva Vault QMS, TrackWise, or MasterControl.
• Strong experience with system validation and regulated SDLC.
• Knowledge of biopharmaceutical Quality processes and regulatory expectations.
• Excellent analytical, documentation, and problem-solving skills.
• Ability to communicate complex technical concepts to non-technical stakeholders.
• Experience in global, matrixed organizations.
• Advanced degree or certifications preferred (CBAP, PMP, CSV, ITIL).

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 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.

Skills

Business analysis

Regulatory communication

Global collaboration

Problem solving

Education

Bachelor’s degree in Information Systems, Engineering, Life Sciences, or related discipline

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

Tools

eQMS platforms (Veeva Vault QMS, TrackWise, MasterControl)

Job description

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

The role requires deep expertise in Quality processes, independence in delivering complex initiatives, and leadership in system optimization, validation strategy, and data integrity, across global sites and functions.