Business Analyst -GXP

Responsibilities

• Evaluate and continuously improve GxP R&D, Clinical and Commercial systems to ensure efficiency, scalability, and compliance with company needs
• Document and analyze the current business processes and workflows to identify opportunities for improvement and automation to reduce manual processes
• Partner with business leaders to understand their needs, develop business cases for new system implementations or enhancements, including cost-benefit analysis and return on investment (ROI) calculations
• Lead end-to-end system selection and implementation projects, including request for projects, requirements gathering, system configuration, testing, training, and post-go-live support
• Create change controls and lead system upgrades, patches, and enhancements to maintain system functionality and security compliance
• Ensure the accuracy and integrity of GxP data through system audits and reconciliations
• Develop and maintain dashboards and reports for leadership to provide insight into business performance and operational metrics
• Ensure all systems comply with FDA regulations, GDPR, and other biotech-related regulatory standards
• Implement, document, and maintain proper security protocols to safeguard sensitive company information, such as patient data, employee information, and proprietary biotech research
• Serve as the first point of contact for troubleshooting and resolving issues related to GxP systems

Requirements

Bachelor's degree in Business, Information Technology, Computer Science, Finance, or a related field. MBA or MS degrees preferred

7+ years of experience as a Business Systems Analyst or similar role, preferably within a biotech, life sciences, or public company

Excellent communication skills to work with cross-functional teams (Clinical, Commercial, Regulatory, Patient Operations, Supply Chain, Manufacturing, Quality, IT) and explain technical details to non-technical stakeholders

Experience supporting Clinical, Regulatory, Commercial, and Quality systems (e.g. CRM, RIMS, DMS, QMS, TMS, LIMS)

Strong knowledge of SQL, data analytics tools, and reporting systems (e.g., Power BI)

Experience in system integrations, configuration, testing, and supporting GxP software solutions

Regulatory Knowledge: Strong understanding of regulatory requirements relevant to GxP environments, including FDA regulations, EU Annex 11, and 21 CFR Part 11 compliance

Ability to perform gap analysis, gather requirements, and design efficient solutions for GxP business processes

Understanding of Drug Development Process and Cell/Gene Therapy principles

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Responsibilities

• Evaluate and continuously improve GxP R&D, Clinical and Commercial systems to ensure efficiency, scalability, and compliance with company needs
• Document and analyze the current business processes and workflows to identify opportunities for improvement and automation to reduce manual processes
• Partner with business leaders to understand their needs, develop business cases for new system implementations or enhancements, including cost-benefit analysis and return on investment (ROI) calculations
• Lead end-to-end system selection and implementation projects, including request for projects, requirements gathering, system configuration, testing, training, and post-go-live support
• Create change controls and lead system upgrades, patches, and enhancements to maintain system functionality and security compliance
• Ensure the accuracy and integrity of GxP data through system audits and reconciliations
• Develop and maintain dashboards and reports for leadership to provide insight into business performance and operational metrics
• Ensure all systems comply with FDA regulations, GDPR, and other biotech-related regulatory standards
• Implement, document, and maintain proper security protocols to safeguard sensitive company information, such as patient data, employee information, and proprietary biotech research
• Serve as the first point of contact for troubleshooting and resolving issues related to GxP systems

Requirements

Bachelor's degree in Business, Information Technology, Computer Science, Finance, or a related field. MBA or MS degrees preferred

7+ years of experience as a Business Systems Analyst or similar role, preferably within a biotech, life sciences, or public company

Excellent communication skills to work with cross-functional teams (Clinical, Commercial, Regulatory, Patient Operations, Supply Chain, Manufacturing, Quality, IT) and explain technical details to non-technical stakeholders

Experience supporting Clinical, Regulatory, Commercial, and Quality systems (e.g. CRM, RIMS, DMS, QMS, TMS, LIMS)

Strong knowledge of SQL, data analytics tools, and reporting systems (e.g., Power BI)

Experience in system integrations, configuration, testing, and supporting GxP software solutions

Regulatory Knowledge: Strong understanding of regulatory requirements relevant to GxP environments, including FDA regulations, EU Annex 11, and 21 CFR Part 11 compliance

Ability to perform gap analysis, gather requirements, and design efficient solutions for GxP business processes

Understanding of Drug Development Process and Cell/Gene Therapy principles

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.