Regulatory Compliance and Deputy Qualified Person

Merck Gruppe; Tres Cantos; Presencial; EUR 55.000 - 75.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company in Madrid is seeking a Deputy Qualified Person to ensure compliance with GMP and manage regulatory aspects of production. The ideal candidate has a pharmacy degree, over 5 years of relevant experience, and is fluent in Spanish and English. This role requires excellent stakeholder management and the ability to navigate complex environments effectively.

Formación

• Minimum 5 years of experience as Qualified Person or in Regulatory Affairs.
• Deep understanding of GMP and quality systems in pharmaceutical manufacturing.
• Knowledge of EU and highly regulated countries regulations.

Responsabilidades

• Ensure products are manufactured in compliance with GMP requirements.
• Coordinate projects and submission strategies.
• Take legal responsibility for batch release.

Conocimientos

Fluent in Spanish

Fluent in English

GMP knowledge

Stakeholder management

Time management

Conflict resolution

Educación

University degree in pharmacy

Herramientas

MS Office

SAP

Descripción del empleo

Overview

Your Role: As Deputy Qualified Person and Site Regulatory expert of manufacturing site in Madrid (Tres Cantos ), you will assure that products are manufactured and tested in compliance with GMP requirements and Marketing Authorizations. You will play a pivotal role in coordinating projects, submission strategies and implementation of changes considering scientific and technical progress.

Who You Are

• You hold a university degree in pharmacy. You bring at least 5 years of experience as Qualified Person and/or Regulatory Affairs field. You have a deep understanding of GMP (Good Manufacturing Practices) and quality systems within pharmaceutical manufacturing.
• Your knowledge of applicable EU and highly regulated countries regulations is current and comprehensive. You are comfortable taking legal responsibility for batch release in compliance with EU directives and applicable quality standards. Your strong stakeholder management and communication skills enable you to navigate complex environments effectively.
• You excel at time management, gaining alignment, and executing strategic activities successfully. You prioritize competing tasks effectively in a fast-paced, dynamic environment. You have a strong ability to resolve conflicts constructively and maintain a solution-oriented mindset.
• You are a proactive driver of change—someone who takes initiative and ensures things get done.
• You are fluent in both Spanish and English. You have advanced skills in standard MS Office and SAP systems.