Senior External Quality Specialist – GMP Drug Product

Johnson & Johnson Co.; Borgo San Michele; On-site; EUR 49,000 - 78,000; Full time

Job summary

Johnson & Johnson is seeking a Quality professional to ensure external quality for synthetic drug products produced at external sites. You will collaborate with site leads and cross-functional teams to maintain high standards of quality, compliance, and patient safety across the supply chain.

The role emphasizes QA review of deviations, CAPAs, change controls, and regulatory commitments, with travel up to 25% and interaction with internal and external partners.

Qualifications

• Bachelor's degree or equivalent in Pharmacy, Science, Engineering or related field.
• 4+ years in quality management/quality assurance in pharma/biotech.
• Experience in GMP environments and external manufacturing quality support.

Responsibilities

• Provide QA oversight for external Synthetics manufacturing, packaging, testing, release and stability.
• Review deviations, CAPAs, change controls, investigations, and quality agreements.
• Monitor supplier performance and risk, ensure compliance with cGMP and ICH requirements.
• Support audits/inspections and technology transfer for external manufacturing partners.

Skills

Quality management

Regulatory compliance

Document control

CAPA

Audit support

SOPs

Education

Bachelor's degree in Pharmacy/Science/Engineering

Tools

Microsoft Office

Quality systems software

Job description

Johnson & Johnson is seeking a Quality professional to ensure external quality for synthetic drug products produced at external sites. You will collaborate with site leads and cross-functional teams to maintain high standards of quality, compliance, and patient safety across the supply chain.

The role emphasizes QA review of deviations, CAPAs, change controls, and regulatory commitments, with travel up to 25% and interaction with internal and external partners.