Senior GMP Data Analytics Analyst (Contractor)

Position Summary

Join ProKidney as a Senior GMP Data Analytics Analyst Contractor to develop and implement data repository and analytics tools supporting pharmaceutical regulated GMP (Good Manufacturing Practices) data. This role focuses on manufacturing and quality domains, offering the opportunity to work on critical data infrastructure that enables regulatory compliance and operational excellence in the biotech/pharma sector.

Essential Duties & Responsibilities

• Analyze business needs and requirements for data and analytics to support regulatory filings and compliance documentation
• Identify, classify, and map data sources across pharmaceutical manufacturing and quality environments
• Build comprehensive data lineage diagrams from data source to analytics-ready datasets
• Determine data curation requirements to organize, clean, manage, and maintain data for reliable analytical use cases
• Provide technical support for data integration, architecture design, transformation, and processing activities
• Develop data governance standards aligned with company and industry best practices, including FDA regulations
• Lead development of critical project documentation including user requirements, design specifications, and configuration specifications
• Develop test scenarios and scripts in partnership with business, technical, and validation team members
• Lead test execution according to established test protocols and monitor results
• Support development of standard operating procedures and go-live documentation
• Provide training to business teams and develop training materials for system implementation
• Deliver regular project updates to stakeholder teams

Required Qualifications

• Education: Bachelor's Degree required
• Experience: 5-10+ years in IT roles focused on business and technical analysis with emphasis on data, business intelligence, and analytics projects
• Proven experience in Biotech/Pharma regulated industry environments
• Hands-on expertise developing requirements, design, and testing documentation
• Demonstrated experience with data analysis and reporting in pharmaceutical GMP environments
• Deep understanding of GMP data sources including Laboratory Management Information Systems (LIMS), Quality Systems, Manufacturing Execution Systems (MES), Data Historians, and related tools
• Design, development, and operational experience with data repository and analytics platforms
• Lifecycle documentation management and validation experience in FDA-regulated environments
• Proficiency in FDA regulations including 21 CFR Part 11 and Computer System Validation (CSV)
• System administration responsibilities background
• Experience leading data analysis and engineering projects
• Strong collaboration and cross-functional teamwork abilities

This is an excellent opportunity for a seasoned data analytics professional to make a direct impact on pharmaceutical innovation while working remotely with flexibility.

💰 Compensation not publicly listed. Market estimate for similar roles: from $85K, varying by experience and location.