Assoc. Dir, External Quality
Core
Oversees quality systems, manufacturing, testing, packaging, storage, and distribution at external entity sites to ensure compliance with regulatory requirements and company policies for pharmaceutical/biologics products.
Role type
Associate Director, External Quality Assurance
Builds
Quality systems and compliance frameworks for external manufacturing sites
Domain
Pharmaceutical/Biotechnology manufacturing and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global GMP knowledge, Quality Systems expertise, Quality Control oversight, Regulatory inspection support, Budget management, Team leadership, Data analysis for quality metrics, Change control management, Complaint management, Product Quality Review oversight
Preferred skills
Multinational corporation QA/QC experience, Significant investigation leadership, Regulatory inspection participation
Technologies
GMP systems, Quality management tools
Responsibilities
Manage a team of Quality Assurance professionals, Execute performance management processes, Ensure compliance with GMP and governmental regulations, Maintain expertise on EQA systems and processes, Compile and analyze quality metrics for trend identification, Oversee product testing and batch documentation review, Ensure permanent audit readiness and regulatory inspection support, Interact with local Health Authorities for compliance
Seniority
Senior, hands-on IC with management responsibilities
