Senior IT PM Quality Lab in Pharma
Core
Lead end-to-end IT projects for Quality Lab systems, ensuring delivery on time, within budget, and to required quality standards while ensuring compliance with regulatory requirements.
Role type
Senior IT Project Manager (Quality Lab)
Builds
Quality Lab systems, Laboratory Information Management Systems (LIMS), and quality-critical IT infrastructure
Domain
Pharmaceutical industry, Quality Assurance, Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
IT Project Management, GxP guidelines, GAMP 5 principles, FDA/EMA regulatory frameworks, LIMS implementation and validation, risk assessment, stakeholder communication, resource allocation, change management, audit trail management
Technologies
LIMS
Responsibilities
Lead and manage end-to-end IT projects for Quality Lab systems, Develop and implement comprehensive project plans including scope definition and risk assessment, Oversee the validation and implementation of Laboratory Information Management Systems (LIMS), Manage cross-functional teams including IT specialists and external vendors, Maintain detailed project documentation including change logs and audit trails, Monitor project performance metrics and provide regular status updates to senior management
Seniority
Senior, hands-on IC