Quality Assurance Validation Manager
Core
Lead validation activities to ensure product quality, operational excellence, and compliance with global regulatory requirements for sterile fill-finish and packaging manufacturing.
Role type
Senior IC Quality Assurance Validation Manager
Builds
Validated state of systems and processes supporting the manufacture of therapeutics and critical products
Domain
Pharmaceutical/Biotechnology manufacturing (Sterile Fill-Finish & Packaging)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP regulations, validation master planning, risk assessment methodologies, statistical analysis, data integrity compliance, change control management, regulatory inspection support, technical writing, equipment qualification, process validation, cleaning validation, computer system validation, utility qualification, analytical instrument qualification
Preferred skills
Lean Manufacturing, continuous improvement methodologies
Technologies
Microsoft Office
Responsibilities
Lead and manage validation activities across manufacturing, laboratory, utility, facility, computerized systems, and analytical instruments; Develop and maintain validation strategies, validation master plans, and project timelines; Oversee the planning, coordination, execution, review, and approval of validation protocols and reports; Partner with project managers and cross-functional stakeholders to establish priorities, monitor progress, and communicate project status; Ensure validation activities comply with FDA, EU, and applicable global regulatory requirements and Quality Assurance standards; Support equipment qualification, process validation, cleaning validation, utility qualification, computer system validation, and analytical instrument qualification programs; Apply risk assessment methodologies and statistical tools to support validation decisions; Drive continuous improvement initiatives to enhance validation processes and operational efficiency; Manage change control activities and assess validation impacts associated with process or system changes; Ensure adherence to data integrity requirements and governance standards across validation activities; Support regulatory inspections, customer audits, and quality assessments; Mentor, develop, and lead validation professionals while fostering a culture of accountability and excellence
Seniority
Senior, hands-on IC with team leadership
