Project Manager, CQV
Core
Lead validation projects for life sciences clients, ensuring compliance with FDA regulations and delivering commissioning, qualification, and validation solutions.
Role type
Senior IC Validation Project Manager
Builds
Compliant validation approaches, protocols, and execution plans for utility, facility, and process equipment
Domain
Life Sciences / Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project management, FDA validation methods, cGMP, risk assessment (FMEA, HAZOP, Fault Tree), protocol development, client interface, scope/cost/schedule/risk management
Preferred skills
EPCMV, Quality by Design, system/process risk assessments, clean utilities validation, bioprocess manufacturing validation, process automation, GAMP methodologies, 21 CFR Part 11, data integrity
Technologies
Project management tools, word processing, financial systems
Responsibilities
Lead teams of validation professionals, develop project scope statements and proposals, coordinate work across functional areas, track project milestones and budget, manage external consultants or vendors
Seniority
Senior, hands-on IC