Position Overview
Job Description:
The Quality Director will be responsible for overseeing and executing the day-to-day quality assurance and quality control operations at Client's manufacturing facilities. This role ensures that all products meet internal quality standards as well as external regulatory requirements (FDA, cGMP, B, etc.). The Quality Director will drive compliance, manage internal audits, and support continuous improvement initiatives in collaboration with cross-functional teams.
Responsibilities:
Oversee the implementation and maintenance of all quality systems, including document control, deviation management, CAPA, change control, and batch release processes.
Lead quality assurance (QA) and quality control (QC) teams across the manufacturing site(s).
Ensure site compliance with FDA, DEA, B, and cGMP regulations.
Support preparation and coordination of regulatory inspections and customer audits.
Mana...