GMP Operational Quality Packaging & Labeling Validation Associate Director
Core
Lead GMP operational quality validation for finished goods packaging and labeling across global regions, ensuring compliance and process robustness from design through commercial launch.
Role type
Senior IC Associate Director of GMP Operational Quality (Packaging & Labeling Validation)
Builds
Validated packaging and labeling processes for global commercial finished goods
Domain
Pharmaceutical manufacturing (oral solid dosage forms)
Required skills
GMP compliance, validation lifecycle management, root cause analysis, Quality-by-Design (QbD), Critical Process Parameters (CPP), Continuous Process Verification (CPV), project management, cross-functional leadership, regulatory audit facilitation
Preferred skills
Contract manufacturing oversight, primary/secondary packaging development, problem-solving methodologies, technical writing, team mentorship, data analysis
Technologies
Esko-Artwork Management System, Oracle (OPM), MS Office, PowerBI, Veeva
Responsibilities
Standardize validation processes globally, manage validation commercialization oversight, establish QbD principles for packaging, oversee OOS/OOT/trending, serve as QA assessor/approver for change plans, lead continuous improvement initiatives, support audit responses
Seniority
Senior, hands-on IC with strategic oversight
