Compliance Lead, Packaging & Technology — Clinical Supply

Johnson & Johnson Co.; Beerse; Presencial; EUR 81.000 - 141.000; Tempo integral

Resumo da vaga

Johnson & Johnson is seeking a Compliance Lead, Packaging & Technology to serve as the end-to-end compliance SME for packaging, labeling, warehousing, and sample flows. You will translate ICH-GxP and regulatory requirements into clear expectations and act as the primary compliance contact for internal and Health Authority audits.

The role involves coordinating inspection readiness, collaborating with QA, and guiding CAPAs and change controls to uphold quality and operational integrity in a

Qualificações

• Strong working knowledge of ICH-GxP principles, quality systems, data integrity, and regulatory expectations.
• Experience supporting deviations, investigations, CAPAs, change controls, audits, inspections, and compliance-risk assessments.
• Fluent English, written and spoken; Dutch is preferred for effective collaboration.

Responsabilidades

• Act as end-to-end compliance lead for P&T, covering packaging, labeling, warehousing, and sample flows.
• Translate regulatory requirements into practical expectations for P&T operations.
• Serve as primary P&T compliance contact for audits and Health Authority inspections, coordinating readiness.
• Coordinate inspection readiness, gather evidence, identify risks, and monitor commitments.
• Liaise with QA, QS, and stakeholders to align compliance priorities across P&T.
• Monitor compliance metrics, maintain governance, and provide data-driven recommendations.
• Guide deviations, investigations, CAPAs, and change controls to ensure action and follow-up.

Conhecimentos

ICH-GxP

Quality systems

Data integrity

Audits & inspections

Risk assessment

Formação

Bachelor’s degree

Ferramentas

Microsoft Office

Descrição da vaga

Johnson & Johnson is seeking a Compliance Lead, Packaging & Technology to serve as the end-to-end compliance SME for packaging, labeling, warehousing, and sample flows. You will translate ICH-GxP and regulatory requirements into clear expectations and act as the primary compliance contact for internal and Health Authority audits.

The role involves coordinating inspection readiness, collaborating with QA, and guiding CAPAs and change controls to uphold quality and operational integrity in a