Manager Quality Assurance
Listed on 2026-10-09
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Quality Assurance - QA/QC
Regulatory Compliance Specialist
Manager of Quality Assurance overseeing external manufacturing for Advanced Therapy products, ensuring compliance with safety, regulatory, and quality standards. Responsibilities include leading quality systems, qualifying and monitoring external partners, investigating and resolving quality issues, reviewing documentation, analyzing metrics for risk management, fostering relationships with stakeholders, supporting inspections, and driving continuous improvements.
Experience & Qualifications8+ years in FDA/EMA-regulated environments, Bachelor's in a scientific or technical field; extensive QA, QC, and compliance knowledge. Must have background in biologics, aseptic manufacturing, and Good Tissue Practices. Skills in regulatory communication and stakeholder influence are preferred.
High-Value DetailsFocus on biologics/Advanced Therapy, experience with GMP, tissue/biosafety standards, and external partner oversight in commercial manufacturing; potential involvement in tech transfer and new product launches.
Work SetupLocation in New Jersey or Pennsylvania (prefer Raritan, NJ), hybrid/remote, with up to 30% travel. The role emphasizes leadership, cross-functional collaboration, and maintaining inspection readiness and compliance across manufacturing sites.
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