Quality Technical and Validation Manager
Core
Ensuring GxP compliance in the validation and qualification of processes, equipment, and systems within pharmaceutical manufacturing and analytical environments.
Role type
Senior IC Quality Technical and Validation Manager
Builds
Validated processes, equipment, and computer systems for medicines and vaccines production
Domain
Pharmaceutical manufacturing / Biotechnology / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP compliance, process validation, equipment qualification, change control management, new product introduction (NPI) oversight, computer system validation (CSV), regulatory standards knowledge, data analysis for validation trends, technology transfer approval
Preferred skills
Advanced degree in scientific/engineering discipline, business requirement identification, complex problem solving, continuous improvement methodologies (Six Sigma, Lean), quality assurance certification (ASQ, ISPE)
Technologies
Robotics, digital solutions, artificial intelligence, computer systems, laboratory automation
Responsibilities
Oversee validation and qualification activities for processes, equipment, and facilities; Determine phase-specific controls for production and laboratory value streams; Provide quality oversight for technology transfer and NPI activities; Develop and approve equipment validation protocols; Monitor and analyze validation data to identify trends; Participate in internal and external audits and inspections; Oversee laboratory business applications and automation
Seniority
Senior, hands-on IC with leadership responsibilities
