Laboratory Systems and Validation Manager
Core
Leading technical operations for quality control of pharmaceutical products, ensuring compliance with cGMP, FDA regulations, and data integrity standards.
Role type
Senior Laboratory Systems and Validation Manager
Builds
Validated QC systems, qualified laboratory equipment, and compliant testing protocols for active pharmaceutical ingredients.
Domain
Pharmaceutical manufacturing / Quality Control / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, software validation (21CFR Part 11, EU Annex 11, GAMP 5), system administration, analytical method validation, cross-functional leadership, technical writing, OOS investigation, CAPA development, SOP creation.
Preferred skills
None stated
Technologies
None stated
Responsibilities
Qualify testing equipment and validate laboratory data systems; administer QC software systems including data backup; lead commissioning and qualification of lab equipment; optimize and validate analytical methods; provide leadership and mentorship to cross-functional teams; champion safety and compliance goals; resolve equipment and testing issues; draft and review technical protocols and SOPs; oversee software development lifecycle for validated systems.
Seniority
Senior, hands-on IC with team management
