Senior Specialist – CMC Data Steward – DSCS Digital
Core
Implement CMC data governance strategy to ensure data quality, compliance, and value realization across cross-functional digital initiatives for pharmaceutical/biotech operations.
Role type
Senior Data Steward (CMC)
Builds
Data governance frameworks, data quality metrics, master data management initiatives, and digital transformation support for regulatory submissions and AI/ML applications.
Domain
Life Sciences / Pharmaceutical / CMC (Chemistry, Manufacturing, and Controls)
Deliverable
production ML models | dashboards & analysis | client delivery
Required skills
Data Governance, Data Quality Management, Master Data Management (MDM), Data Modeling, Data Standards, CAPA (Corrective and Preventive Actions), Stakeholder Management, Regulatory Compliance
Preferred skills
Enterprise Systems (SAP, LIMS, ELN, MES, Veeva), CMC Operations, Manufacturing Scale-Up, New Product Introduction (NPI), Predictive Modeling
Technologies
SAP, LIMS, ELN, MES, Veeva
Responsibilities
Define and document data standards, business rules, metadata, and controlled vocabularies; Monitor data quality metrics and lead root-cause investigations; Partner with Manufacturing, R&D, Quality, Supply Chain, Regulatory, and IT teams; Drive master data management initiatives.
Seniority
Senior, hands-on IC
