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.

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