Sr Data Analyst - Quality & Compliance

Taconic Biosciences, Inc.

1d•$70,000 - $75,000•Remote

About The Position

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 Role: The Sr Data Analyst - Quality & Compliance will build a centralized, defensible quality data ecosystem that: Connects siloed QMS and compliance systems Enables leading and lagging risk indicators Automates documentation and approval workflows Supports inspection readiness and regulatory governance Builds stand up dashboards and conversational AI interfaces that enable quality and compliance teams ask questions of their data in plain language, and automate the documentation workflows that keep the company compliant across a complex regulatory landscape

Requirements

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

Nice To Haves

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

Responsibilities

Quality & Animal Welfare Data Architecture & Integration
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
Quality & Animal Welfare Risk and Performance Analytics
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
Approval, Change Control & Compliance Workflow Automation
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
Inspection & Regulatory Readiness
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
Independent Technical Leadership
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

Benefits

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