The individual is responsible for the development and maintenance of Quality Systems at the West Point site in accordance with cGMPs and international regulations, guidelines, procedures, and policies.
The Associate Director, Aggregate Report Quality (ARQ) is responsible for leading and performing activities which support aggregate safety reports, audits/inspections, IT output quality management and aggregate submission activities.
In this role, you will be responsible for ensuring that our products meet standards set by both the company and regulatory authorities. Coordinates and investigates corrective/preventive actions of the Food Safety and Quality Programs. Develops and reviews quality and safety policies and manages audits by third-party inspectors. Trains
In this role, the selected candidate will provide innovative direction and guidance on reports, communications, and training materials and ensure recommendations are aligned with customer/organization needs and capabilities.
The incumbent develop and execute the strategy for all Quality and GMP compliance related activities relating to the analytical testing and release of biologics and therapeutic protein drug substance across the line of business to ensure compliance with all applicable regulations and specifications.
The Compliance Operations Quality Management Director will establish a new Quality Management function within CE&E by building on previous monitoring and audit work and creating a total quality management model.
The Global Director of Quality will lead a team of Quality professionals across multiple sites who work closely with Operations and Commercial teams to ensure Customer requirements are understood and met.