GMP Operational Quality Packaging & Labeling Validation Associate Director

Role: Associate Director of GMP Operational Quality Assurance, a senior technical expert responsible for overseeing validation projects related to commercial product launch and continuous improvement, ensuring compliance with global regulatory standards. Responsibilities: standardize validation processes, manage validation and process robustness from design through supply, provide quality guidance for investigations, support lifecycle management, establish Quality-by-Design principles, oversee external manufacturing quality, develop validation frameworks, and lead continuous improvement initiatives. Qualifications: Master's degree with 5-8 years or Bachelor's with 9+ years in scientific or related fields; extensive experience in GMP manufacturing, validation, and quality oversight; strong project management and leadership skills; proficiency in GxP regulations, validation, and quality systems. Preferred: experience with contract manufacturing organizations, primary/secondary packaging (oral solid dosage preferred), regulatory audits, and technical tools like PowerBI, Veeva, Oracle; demonstrated ability to lead complex projects and collaborate across functions. High-Value: focuses on GMP validation for finished goods, global market supply, process development, and compliance. Work setup: details not specified, but involves cross-functional and external partner collaboration, likely in a regulated manufacturing environment.