Sr. Specialist External Quality
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Johnson & Johnson seeks a Senior Specialist in External Quality to oversee quality assurance and compliance for synthetic drug products manufactured by external partners in Latina, Italy. The role involves monitoring external manufacturers, reviewing quality documentation, managing risk, and supporting regulatory compliance across manufacturing, packaging, testing, and supply operations.
Responsibilities
Provide quality assurance oversight for external synthetic product manufacturing, packaging, testing, release and supply activities
Review and approve deviations, non-conformances, investigations, CAPAs, change controls and quality agreements for external partners
Monitor quality and compliance performance of external manufacturers using metrics, audit outcomes and supplier performance data
Identify and escalate quality, compliance and supply risks with timely mitigation plans
Support external manufacturers during J&J audits, health authority inspections and technology transfer initiatives
Requirements
Bachelor's degree in Pharmacy, Science, Engineering, or related technical discipline
Minimum 4 years of quality management or quality assurance experience in pharmaceutical/biotechnology
Experience in GMP-regulated environments, preferably supporting external manufacturing operations
Working knowledge of cGMP, ICH requirements, and quality systems
Ability to review quality records, identify gaps, and support root cause analysis
Excellent written and verbal communication skills with internal and external stakeholders
Proficiency in Microsoft Office and quality system tools
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