KBI: US - IT Business Systems Analyst

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

Job Summary

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. The role demonstrates deep expertise in Quality processes and regulated systems, independently manages complex initiatives, and provides thought leadership on system optimization, validation strategy, and data integrity.

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 work force.

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.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them.

We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of ones technical skills.

At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.

If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently.