IT Project Manager Quality Systems (eQMS) in Pharma
Lead the global eQMS consolidation program to unify multiple quality management systems into a single, scalable Veeva-based solution across various sites.
We are looking for Senior MLOps specialist. It will be full-time for about 3 months. We are flexible on location and rate for the right person.
Mission
• Build and run a scalable, traceable, FDA-ready data platform bridging on-prem DGX and AWS for our 2026 submission.
Key responsibilities
• Implement ingestion + QC automation starting with CT DICOM, expanding to video/C-Arm and radiology reports.
• Implement/operate distributed processing on AWS Batch (Spot) for large-scale QC + predictions + derivatives.
• Deploy ClearML for dataset versioning/lineage and experiment tracking (runs/metrics/artifacts; provenance).
• Optimize training data access using Lance (or equivalent) for fast loading and incremental updates.
• Build a PostgreSQL-backed enrichment service for metadata/labels/predictions independent of raw media (optional search via OpenSearch/text+vector).
• Integrate/operate labeling workflows (Encord preferred; alternatives acceptable), incl. RBAC/QC/audit trail + algorithmic label ingestion.
• Establish a governed clinical validation environment meeting 21 CFR Part 11 expectations (access control, audit trail/WORM, provenance) and HIPAA/PHI handling.
Requirements
Python, AWS (S3, AWS Batch, EC2 Spot), Kubernetes, HPA, Karpenter, Networking (VPC, VPN UiFI), Trivy, Jenkins, PostgreSQL, DICOM, PACS, Orthanc, ClearML, Lance, Encord, OpenSearch, FFmpeg
Knowledge: Medical imaging (CT, DICOM), data ingestion pipelines, data quality (QC) automation, distributed data processing, experiment tracking and dataset versioning, metadata and label management, clinical AI validation, 21 CFR Part 11 compliance, HIPAA/PHI handling, RBAC, audit trails, WORM storage, vector search, media processing, annotation/labeling workflows, provenance and data lineage, PACS integration, radiology workflows.
Benefits
Lead the global eQMS consolidation program to unify multiple quality management systems into a single, scalable Veeva-based solution across various sites.
Lead a global eQMS consolidation program to unify multiple quality management systems into a single Veeva-based solution, enhancing efficiency and compliance across sites.
As a Senior IT Data Project Manager, you will lead and deliver data-related projects, ensuring alignment between technical delivery and business requirements in the pharma industry.
As a Senior IT Data Project Manager, you will lead data domain projects, ensuring successful delivery through effective coordination with stakeholders and technical teams.
As a Senior IT Data Project Manager, you will lead data domain projects, ensuring successful delivery through effective coordination with stakeholders and technical teams.