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,  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.
Partner with IT Compliance to ensure all systems comply with FDA regulations, GDPR, and other biotech-related regulatory standards.
Collaborate with validation engineers on authoring of system validation documentation.
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.
Strong knowledge of Computerized Systems Validation (CSV) and Computer Software Assurance (CSA) principles within GxP-regulated environments.