Sr Data Analyst - Quality & Compliance
We are looking for a senior, hands-on Data Architect with applied analytics capability to design and operationalize enterprise-grade data and reporting framework supporting Quality Management Systems (QMS) and regulatory compliance within the Animal Welfare and Integrity office.
This role serves as the sole data and analytics practitioner for the function, responsible for integrating fragmented quality and compliance data, enabling risk-based decision-making, and automating audit-ready workflows supporting Quality, Compliance, Animal Welfare, Biosecurity, and Genetic Integrity programs. This position operates at the intersection of regulatory compliance, quality & animal welfare assurance, risk governance, and enterprise data strategy.
The Location: Remote role
The Pay Range: $70,000 - $75,000. Exact compensation may vary based on several factors. These factors include geographic location, experience, training, education, and local market conditions
What we offer:
- Relocation assistance
- Insurance within 30 days or less which includes options for medical, dental, vision, pet insurance and more!
- 20 days paid time off plus 6 additional holidays and 1 floating holiday
- Annual Bonus Program
- Work life balance
- 401(k) plan with up to 4% employer match
- Tuition reimbursement
- Career advancement opportunities
- Commitment to training and providing you with the skills you need for success
- All employees receive access to 24/7 telemedicine (including mental health), short- and long-term disability and life insurance
- Connects siloed QMS and compliance systems
- Enables leading and lagging risk indicators
- Automates documentation and approval workflows
- Supports inspection readiness and regulatory governance
- Architect and maintain a centralized data layer integrating:
- QMS, CAPA/RCCA, and non-conformance systems
- Clinical, genetic, environmental, biosecurity monitoring data
- Design validated data schemas and controls to ensure auditability and regulatory defensibility
- Build lightweight ETL/ELT pipelines across databases, spreadsheets, and document-based systems without disrupting source platforms
- Develop leading and lagging quality indicators dashboards, including:
- Deviation trends, recurrence, and velocity
- Change control backlog, aging, and approval cycle times
- Training compliance drift
- Repeat CAPAs and systemic failure patterns
- Construct weighted risk indices to support risk-based prioritization & RCCA escalation
- Create a unified data layer or knowledge graph that enables cross-system queries
- Deliver executive-ready dashboards for Performance Integrity Review Boards and compliance leadership
- Build self-service reporting tools so quality and compliance teams can answer routine questions without submitting data requests (example: “Show me all GLP deviations from Q3” or “What’s the status of our USDA renewal?”
- Implement appropriate guardrails for accuracy and data access control
- Automate regulatory protocol and documentation approvals & submissions, change control, and CAPA workflows:
- Template generation and data auto-population
- Approval routing and status tracking
- Traceability across related quality and regulatory events
- Integrate automation into existing QMS platforms rather than replacing them
- Reduce manual effort, error rates, and cycle time
- Automate the generation, assembly, and routing of regulatory compliance documents across FDA/GLP, USDA/AAALAC, IACUC, and export control workflows
- Build templates, auto-population logic, and approval-routing automation to reduce manual effort and error rates
- Build dashboards supporting inspection readiness, audit response, & accreditation
- Analyze historical findings, deviations, and corrective actions to identify systemic risk
- Support defensible, data-backed narratives for regulators and accrediting bodies
- Own tool selection, architecture decisions, implement within IT & security constraints
- Translate complex data and analytics concepts into actionable insights for non-technical leaders and team members
- Operate autonomously with minimal dedicated IT support
- Other duties as assigned
- Bachelor's degree preferred, relevant experience, or combination of education and experience will be considered in lieu
- 5+ years of hands-on experience in data engineering, analytics, or applied data science in regulated environments
- Experience with automation pipelines and workflow triggers
- Experience integrating data from QMS, compliance or LIMS systems
- Proven ability to build dashboards in Power BI, Tableau, Looker, or similar tools
- Experience working with siloed, incomplete, inconsistent, and regulated datasets across multiple systems and formats
- Experience with compliance KPIs, audit readiness, and operational metrics
- Strong proficiency in SQL, and/or Python, ETL, or similar
- Experience in quality, life sciences, biotech, or pharmaceutical environments
- Experience with CAPA/RCCA and change control governance
- Familiarity with ISO, FDA, GxP, USDA, AAALAC, or IACUC frameworks
- Comfort operating as a solo technical practitioner: you scope your own work, choose your own tools, and troubleshoot without a team around you
- Strong communication skills — you will be the translator between data/AI capabilities and regulatory compliance needs
- The work is sedentary. Typically, the employee may sit comfortably to do the work, with some walking; standing; bending; carrying items such as papers, books, small parts; driving an automobile; etc. No special physical demands are required to perform the work. Generally, no adverse environmental conditions are present.