Associate Director, Quality Systems and Compliance

Serán is seeking an Associate Director, Quality Compliance who will be responsible for leading the Quality Compliance program to ensure ongoing adherence to applicable GxP regulations, client requirements, industry standards, and internal Quality Management System (QMS) requirements. This role serves as the primary owner of inspection readiness, regulatory inspection management, client audit support, internal audit programs, supplier quality oversight, management review, quality metrics, and compliance monitoring activities.

This position serves as the independent quality oversight function responsible for evaluating the effectiveness of Quality Management System processes and ensuring sustained compliance with regulatory, client, and internal quality requirements. The Associate Director partners closely with Manufacturing, Quality Control, MSAT, Supply Chain, Regulatory Affairs, Engineering, Validation, and Quality Systems to foster a proactive quality culture and ensure sustainable compliance as the organization advances commercial manufacturing capabilities.

This position serves as a key Quality leader during regulatory inspections, client audits, and internal quality reviews, and drives continuous improvement initiatives related to cGMP compliance oversight.