Manager Quality Assurance

Role: Manager, Quality Assurance overseeing external manufacturing of Advanced Therapy products, ensuring compliance with safety, regulatory, and quality standards. Responsibilities: lead quality systems, oversee partner qualification and monitoring, manage investigations, review validation and technical documentation, analyze metrics for risk mitigation, foster relationships with partners, support inspection readiness, and drive continuous improvement initiatives. Qualifications: 8+ years in FDA/EMA-regulated environments; Bachelor’s in science or related field; extensive QA/QC knowledge; experience with biologics, aseptic manufacturing, and Good Tissue Practices; strong communication skills. Preferred: analytical skills and regulatory writing experience. High-Value: biologics, Advanced Therapy, external manufacturing oversight, compliance with GxP and regulatory inspections. Work Setup: hybrid with up to 30% travel; locations in New Jersey or Pennsylvania.