Description

The Associate Director, Quality Assurance provides strategic leadership and oversight of the site Manufacturing Operations to ensure compliance with the applicable regulations such as: FDA regulations (21 CFR Parts 210, 211, and 820 as applicable), EU GMP, and ISO 13485 standards.

This role is accountable for Quality oversight across the manufacturing process of formulation, filling, triton and Cascade Water Sterilization process (CWS). The position supports and oversight contamination control strategies, risk-based decision-making, and sustainable compliance culture, while enabling operational excellence and supply continuity.

The Associate Director acts as a key member of the site quality leadership team, driving quality strategy, regulatory readiness, and continuous improvement initiatives aligned with global and site objectives.

Works collaboratively with Manufacturing, Supply Chain, EHS, Engineering, and other cross-func...