Senior Mgr, IT GxP Business Partner

Responsibilities

• Manage the strategy and execution of GxP R&D, Clinical and Commercial systems to ensure efficiency, scalability, and compliance with company needs.
• Document, analyze, and optimize 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 full lifecycle of system implementation from selection through go-live support, including request for projects, requirements gathering, system configuration, validation, testing, training, and post-go-live support.
• Create change controls and lead system upgrades, patches, and enhancements to maintain system functionality and security compliance.
• Champion IT governance and compliance, driving continuous improvement of policies, procedures, and best practices for GxP system implementation and validation.
• Ensure the accuracy and integrity of GxP data through system audits and reconciliations.
• Develop and deliver actionable dashboards and reports to provide leadership with insights into business performance, system health, and operational metrics.
• Ensure all systems comply with FDA regulations, GDPR, and other biotech-related regulatory standards.
• Develop system validation documentation and manage validation engineers.
• Implement, document, and maintain proper security protocols to safeguard sensitive company information, such as patient data, employee information, and proprietary biotech research.
• Act as escalation point and hands-on problem solver for critical GxP system issues, balancing strategic oversight with operational responsiveness.
• Partner with IT leadership to create cross functional roadmap of GxP systems

Requirements

• Bachelor’s degree in Business, Information Technology, Computer Science, Finance, or a related field. MBA or MS degrees preferred.
• 10+ 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.
• Strong analytical skills to understand complex business processes and system requirements.
• Ability to translate business needs into technical requirements and system solutions.
• Expertise in process improvement and finding efficiencies within existing systems and processes.
• Strong project management skills with the ability to work on multiple projects simultaneously.
• Ability to influence and collaborate with senior leadership and stakeholders.
• Excellent organizational skills and attention to detail.
• Customer-focused mindset with a proactive approach to solving issues.