Director Quality Assurance, Drug Substance Manufacturing

Lead the QA startup strategy for the Saratoga Drug Substance facility, including quality systems build-out, staffing, and readiness for design review, commissioning, qualification, and process validation. Define automation, systems integration, and data integrity requirements to enable review-by-exception batch record disposition. Partner with Automation, Engineering, and IT functions to design exception-based quality control strategies, including electronic batch record rules and real-time release criteria. Build and maintain a high-performing team of managers, providing direction, setting performance standards, and ensuring manufacturing quality staff are appropriately trained for a highly automated environment. Establish data integrity governance for automated systems, ensuring ALCOA+ principles and 21 CFR Part 11/Annex 11 compliance are designed into the facility from startup. Provide first response for Quality and Compliance issues on the manufacturing floor, including exception review, in-process testing oversight, and final QA approval of deviations and change documentation. Lead cross-functional teams to drive projects through completion within timeline, quality, and budgetary constraints while representing the Company during regulatory body inspections.