Senior Specialist, Supplier Quality
New Brunswick, Middlesex County, New Jersey, 08933, USA
Listed on 2026-10-06
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
Senior Specialist, Supplier Quality within Johnson & Johnson’s Innovative Medicine External Quality team, focusing on supplier lifecycle management for biotherapeutics, synthetics, and advanced therapies.
Responsibilities:manage supplier selection, qualification, risk assessment, performance monitoring, and issue resolution; oversee quality management system activities such as nonconformances, investigations, change control, and audits; collaborate with site QA teams and support inspections; lead supplier relationship development and quality projects across global sites; shape management practices for complex supply chains involving advanced therapies and critical technologies; act as liaison for indirect material suppliers.
Requirements:Bachelor’s degree (Science, Engineering, or Technical preferred); minimum of 5 years’ experience in product/supplier lifecycle management in GMP-regulated environments; knowledge of EQ/SQ QMS, GMP, ICH regulations, and regulatory inspections; ability to build cross-functional collaboration; travel up to 15%.
Competencies:strong understanding of biologics, synthetic, and advanced therapy product quality; excellent communication, analytical, and remote working skills; influence in matrix organizations.
High-Value:supplier management in biologics and advanced therapies, GMP compliance, regulatory inspections, global collaboration, and quality systems expertise.
Work setup:multiple US locations and remote options, with some travel.
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