Position OverviewPosition Description We are hiring a Director Data, AI and Analytics. The Director Data, AI and Analytics will own the strategy, platforms, operating model, and outcomes for Data, AI, and Analytics across three FUJIFILM life-sciences businesses. In highly regulated GxP environments, deliver a trusted data backbone, governed self-service analytics, advanced analytics, bioinformatics pipelines, and agentic AI-meeting 21 CFR Part 11/EU Annex 11, ALCOA+, and CSV/CSA expectations. Lead a cross-site team (CoE + domain squads), partner with QA/CSV, Security, Lab IT, M&Q Systems, and ERP, and convert data and AI into measurable business value.
This position is hybrid in Irvine, CA.Job DescriptionResponsibilities:- 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.
Required Skills/Education: - BS/BA (or equivalent) in Business, Computer Science or similar.
- 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.
Salary and Benefits:- For California, the base salary range for this position is $154,565.00 - $216,100. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
- Medical, Dental, Vision
- Life Insurance
- 401k
- Paid Time Off
*#LI-hybrid
