Associate Director Quality Assurance
Core
Principal quality assurance engineer leading the design, construction, and validation of a new pMDI manufacturing facility in China.
Role type
Senior IC Quality Assurance Engineer (Capital Projects)
Builds
New pMDI manufacturing facility and associated quality systems
Domain
Pharmaceutical manufacturing / GMP compliance / Capital projects
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, validation lifecycle management, deviation and change control, China legislation, cross-functional stakeholder management, team mentorship, digital process design
Preferred skills
Expertise in automation digital processes, database oversight (GPQS, ECMS, GVLMS), regulatory trend analysis
Technologies
GPQS, ECMS, GVLMS
Responsibilities
Ensure GMP compliance during design, construction, and start-up phases; lead validation programs for facility, equipment, and utilities; mentor QA and engineering staff; oversee contractors and interns; interface with engineering, IT, QC, and manufacturing functions; develop departmental processes and training.
Seniority
Senior, hands-on IC with leadership accountabilities
