Sr. Director, Quality Control

Role: Senior Director of Quality Control (QC) overseeing outsourced GxP testing for clinical and commercial products in a contract manufacturing environment. Responsibilities: establish and manage external QC systems, vendor selection and performance, release and stability testing frameworks, investigation governance for OOS/OOT, reference standard and reagent programs, raw material testing, analytical method validation and transfer, specification and material qualification management, QC partnership with QA, regulatory compliance, and inspection readiness; lead cross-functional collaboration with manufacturing, R&D, regulatory, and legal teams. Requirements: Bachelor’s degree in biotechnology, chemistry, or related field; 18+ years’ pharma QA/QC experience, including 12+ years supporting GxP clinical and commercial products; strong knowledge of quality systems, investigations, CAPAs, and regulatory interactions. Preferred: advanced technical degree. High-Value: expertise in GxP environments for biologics or pharmaceuticals, regulatory submissions (INDs, NDAs, BLAs), stability data management, and external vendor oversight. WorkSetup: based in Chicago HQ, minimum 4 days/week onsite; periodic travel may be required.