Senior External Quality Specialist: GMP & Compliance

Johnson & Johnson Co.; Latina; On-site; EUR 75,000 - 90,000; Full time

Job summary

Johnson & Johnson is seeking an External Quality Senior Specialist to ensure quality and compliance for externally manufactured synthetic drug products. You will collaborate with External Quality Site Leads and cross-functional teams to uphold cGMP standards and regulatory commitments.

You will contribute to continuous improvement, risk management, and lifecycle management of external manufacturers while supporting audits and technology transfer initiatives.

Qualifications

• Bachelor’s degree or equivalent in Pharmacy, Science, Engineering, or related technical discipline.
• Minimum 4 years in quality management, QA, production, QC, R&D, or related pharma/biotech environment.
• GMP-regulated environment experience; QA support for external manufacturing preferred.

Responsibilities

• Provide QA oversight for external synthetic drug products and supplier activities.
• Review and approve deviations, investigations, CAPAs, change controls, complaints and batch records.
• Monitor external manufacturers using quality metrics, audit outcomes, inspections, and supplier data.
• Identify and communicate quality or supply risks and support mitigation plans.
• Support qualification, monitoring, and lifecycle management of external manufacturers and partners.
• Collaborate with QA, MSAT, Planning, Regulatory, EHS, and external partners to ensure patient supply.
• Assist during audits/inspections and regulatory commitments, including preparation and action follow-up.
• Participate in technology transfer, product lifecycle management, and process improvement initiatives.
• Contribute to continuous improvement of External Quality processes and documentation practices.

Skills

Quality Assurance

Quality systems

Audit support

CAPA

Risk management

Documentation

Communication

Education

Bachelor’s degree

Job description

Johnson & Johnson is seeking an External Quality Senior Specialist to ensure quality and compliance for externally manufactured synthetic drug products. You will collaborate with External Quality Site Leads and cross-functional teams to uphold cGMP standards and regulatory commitments.

You will contribute to continuous improvement, risk management, and lifecycle management of external manufacturers while supporting audits and technology transfer initiatives.