Director, Data, AI & Analytics — Life Sciences (Hybrid)

FUJIFILM Biosciences; Irvine (CA); Hybrid; USD 154,565 - 216,100; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

401k

Paid Time Off

Job summary

FUJIFILM Biosciences is seeking a Director of Data, AI and Analytics to own strategy, platforms, operating model and outcomes across three life‑sciences businesses. In regulated GxP environments, deliver a trusted data backbone, governed self‑service analytics, bioinformatics pipelines, and agentic AI—meeting 21 CFR Part 11/Annex 11, ALCOA+, and CSA expectations.

Lead a cross-site CoE and domain squads; partner with QA/CSV, Security, Lab IT, and ERP to drive measurable business value.

Qualifications

• 10+ years leading Data/Analytics functions with 5+ years in regulated life sciences (biotech, pharma, CDMO); multi-site/global experience.
• Ownership of enterprise data platforms (lakehouse/warehouse), analytics programs, and MLOps in production.
• Strong GxP/CSV/CSA knowledge with practical application in analytics/AI and data flows; 21 CFR Part 11/Annex 11/ALCOA+.
• Hands-on familiarity with bioinformatics analytics/pipelines (e.g., NGS/omics, imaging, workflow orchestration) and integration with LIMS/ELN and lab systems.
• Proven record converting Data/AI programs into business outcomes (e.g., cycle time, yield/FPY, cost, quality).
• Cross-functional leadership with QA/CSV, Manufacturing/Quality, R&D, Security, ERP/MES/QMS owners, and vendors.
• Excellent executive communication and pragmatic technical guidance.
• Platforms: Databricks/Snowflake/BigQuery; Azure/AWS data services; Spark; DBT; Airflow/Prefect; Kafka/EventHub.
• BI: Power BI/Tableau; semantic/metrics layers; KPI governance.
• MLOps/AI: MLflow/W&B, SageMaker/Azure ML; vector DBs/RAG; LLM orchestration; agent frameworks; feature stores.
• Bioinformatics: Nextflow/Snakemake, CWL/WDL; common tools (e.g., GATK) or imaging/omics pipelines; HPC/containers.
• Governance: Collibra/Alation/Atlan; model risk management/AI governance.
• Certifications: GAMP 5/CSA, ITIL, cloud (Azure/AWS), or data governance certifications.
• Ability to speak, read, and write in English.
• Good verbal and written communication skills; effective presentation skills.

Responsibilities

• Define the multi-year Data/AI roadmap for locations in California and Wisconsin; align to business priorities and compliance needs.
• Stand up a Data, AI & Analytics Center of Excellence with domain-aligned product squads (M&Q, R&D/Bioinformatics, Finance/SC).
• Run governance: Data & AI Steering Committee, Model Risk & Compliance Board; assign data product ownership.
• Own the enterprise data platform (lakehouse/warehouse), ingestion (ELT/CDC), orchestration, and semantic/metric layers.
• Implement catalog/lineage, data quality rules, access controls; drive data product SLAs and ownership.
• Integrate core systems: MES (e.g., PAS-X), QMS (ETQ/Veeva), LIMS/ELN (LabWare/Benchling), ERP (e.g., SAP/Oracle), OSI PI/AVEVA, and instrument data hubs.
• Deliver executive and operational analytics (FPY/yield, OEE, deviation/CAPA TAT, batch release, QC throughput, inventory turns, cost-to-serve).
• Enable governed self-service (certified datasets/semantic models, KPI library, training, community of practice).
• Lead data science programs for manufacturing quality, supply chain, and R&D.
• Own bioinformatics analytics and pipelines (e.g., NGS/omics workflows, imaging pipelines, assay analytics) and integration with lab systems and data platforms.
• Build responsible and agentic AI capabilities (assistants/co-pilots, retrieval/grounding, task automation) with MLOps (experiment tracking, model registry, CI/CD, monitoring, retraining). Separate GxP vs non-GxP AI; ensure intended use, explainability , validation/CSA, and periodic review for regulated models.
• Embed compliance by design: 21 CFR Part 11, Annex 11, ALCOA+, data retention/archival, audit trails.
• Partner with QA/CSV on risk-based validation, test evidence, and inspections; maintain validated state for applicable analytics/data flows.
• Coordinate with Corporate Security on classification, RBAC/least privilege, encryption, logging/monitoring, and incident response for data/AI workloads.
• Govern AI safety: model cards, red-team testing, bias/fairness checks, PHI/PII safeguards, vendor due diligence.
• Prioritize a portfolio of use cases with quantified value; pilot, scale winners, retire low-value work.
• Publish a quarterly “Data & AI Outcomes” report (business impact, adoption, cost/performance, compliance posture).
• Select and govern platform vendors (cloud, data/ML, BI, bioinformatics tools) and SIs; negotiate commercials, SLAs, exit terms.
• Drive FinOps: usage visibility, rightsizing, tiered storage, and cost/performance optimization.
• Hire and develop data/platform/analytics engineers, data scientists/ML engineers, bioinformatics engineers, and product managers.
• Build cross-site career paths and a culture of reliability, compliance, and measurable impact.

Skills

Data strategy

Regulated life sciences

GxP/CSV/CSA

Leadership

MLOps

Bioinformatics

Data platforms

Executive communication

Databricks/Snowflake/BigQuery

Power BI/Tableau

Education

BS/BA in Business, CS or similar

Tools

DBT

Airflow

Kafka

Collibra/Alation

Job description

FUJIFILM Biosciences is seeking a Director of Data, AI and Analytics to own strategy, platforms, operating model and outcomes across three life‑sciences businesses. In regulated GxP environments, deliver a trusted data backbone, governed self‑service analytics, bioinformatics pipelines, and agentic AI—meeting 21 CFR Part 11/Annex 11, ALCOA+, and CSA expectations.

Lead a cross-site CoE and domain squads; partner with QA/CSV, Security, Lab IT, and ERP to drive measurable business value.