Manager Quality Assurance

Role: Manager, Quality Assurance overseeing external manufacturers of Advanced Therapy products, ensuring compliance with safety, regulatory, and quality standards. Responsibilities: lead quality systems and controls, manage partner qualification and monitoring, resolve quality issues with CAPA plans, review and approve quality documentation, analyze metrics for risks and improvements, foster relationships with partners, support inspections and compliance, and drive continuous improvement and tech transfer activities. Requirements: 8+ years in an FDA/EMA-regulated environment, bachelor's in a scientific or technical discipline, extensive QA/QC and compliance knowledge, familiarity with GMP, biologics, aseptic manufacturing, and Good Tissue Practices. Preferred: strong analytical skills and experience with regulatory communications. High-value: biologics, aseptic processes, biologics products, external manufacturing oversight, regulation compliance, and cross-functional stakeholder influence. Work setup: based in New Jersey or Pennsylvania, with up to 30% travel. Position emphasizes leadership in quality assurance for complex biopharma manufacturing, ensuring product integrity and regulatory readiness.