EU Regulatory Inspection Readiness Consultant

G&L Scientific; United States; A distancia; USD 120.000 - 170.000; Jornada completa

Descripción de la vacante

G&L Scientific is seeking an experienced Inspection Readiness Consultant to help pharmaceutical and biotech clients prepare for EMA inspections and other international regulatory reviews. You will assess compliance, identify gaps, and coach teams for inspection readiness across GCP, GMP, GVP, GLP and GDP contexts.

You will lead mock inspections, CAPA planning, and pre-inspection activities, coordinating with senior stakeholders and internal SMEs to deliver timely, data-driven readiness.

Formación

• Eight+ years in pharma/biotech/CRO with QA, regulatory compliance or inspection work.

Responsabilidades

• Lead inspection readiness strategy and planning for EMA/regulatory inspections.

Conocimientos

Regulatory compliance

GxP knowledge

Stakeholder coaching

Project management

Regulatory inspections

Quality systems

Educación

ASQ CQA or IRCA qualification

Descripción del empleo

G&L Scientific is seeking an experienced Inspection Readiness Consultant to help pharmaceutical and biotech clients prepare for EMA inspections and other international regulatory reviews. You will assess compliance, identify gaps, and coach teams for inspection readiness across GCP, GMP, GVP, GLP and GDP contexts.

You will lead mock inspections, CAPA planning, and pre-inspection activities, coordinating with senior stakeholders and internal SMEs to deliver timely, data-driven readiness.