IT Business Systems Analyst

This is a fully remote position, open to applicants in Colorado, +1 more state.

📋 Description

• Lead the gathering of requirements, mapping of processes, and conducting gap analyses for Quality Systems, encompassing eQMS, CAPA, Deviations, Change Management, and Audit Management.

• Convert business and regulatory needs into functional and technical specifications.

• Collaborate with Quality and business operations to create compliant and efficient system solutions.

• Ensure systems adhere to GxP, 21 CFR Part 11, Annex 11, and ALCOA+ data integrity principles.

• Assist in system validation activities, which include validation planning, risk assessments, IQ/OQ/PQ, and change control.

• Serve as a subject matter expert for Quality Systems during audits and inspections.

• Oversee or assist with system lifecycle activities such as implementation, upgrades, enhancements, and decommissioning.

• Identify opportunities for automation, standardization, and integration of systems.

• Assess vendor solutions and aid in the selection of systems.

• Provide guidance to Quality leadership regarding system capabilities and roadmap planning.

• Facilitate cross-functional workshops and working groups.

• Mentor junior analysts and contribute to the best practices in business analysis and validation.

• Support data governance, reporting, and analytics for Quality metrics and KPIs.

• Manage complex initiatives related to Quality Systems across multiple regions or sites.

• Operate independently with minimal supervision, addressing non-routine issues that require judgment, regulatory knowledge, and alignment with stakeholders.

⛳️ Requirements

• Bachelor’s degree in Information Systems, Engineering, Life Sciences, or a relevant field.

• 6–10 years of experience in business systems analysis.

• A minimum of 4–6 years of support for GxP-regulated Quality Systems in the pharmaceutical or biotechnology sector.

• Demonstrated experience with eQMS platforms such as Veeva Vault QMS, TrackWise, or MasterControl.

• Strong expertise in system validation and regulated Software Development Lifecycle methodologies.

• Comprehensive understanding of biopharmaceutical Quality processes and regulatory expectations.

• Excellent analytical, documentation, and problem-solving capabilities.

• Capability to convey complex technical and regulatory concepts to non-technical stakeholders.

• Experience in global, matrixed organizations.

• Knowledge of FDA 21 CFR Part 11, Annex 11, and global regulatory standards.

🏝️ Benefits

• EEO/AA employer.

• Equal employment opportunity for qualified applicants regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status.

• At-will employment.