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Global Validation Lead

1 semana atrás

Lisboa, Lisboa, Portugal Buscojobs Portugal Tempo inteiro

Job Overview

We are seeking a seasoned validation professional to lead and manage validation activities across various project settings, from SAP implementation to transformational projects.

This role will cover qualification activities, computer system validation, process validation, and ensuring compliance with regulatory standards.

The ideal candidate will bring a deep understanding of validation processes, strong leadership skills, and the ability to navigate complex project environments.

  • Key Responsibilities
  • Develop and implement robust validation strategies that ensure compliance while maintaining seamless operations.
  • Lead and oversee all operational validation or quality-related activities within the client's organization.

Required Skills and Qualifications

  • Bachelor's or master's degree in natural sciences, information technology, engineering, pharmacy, or a related field.
  • A proven track record with 5+ years of experience in a validation manager or quality assurance role within the pharmaceutical or life sciences industry.
  • Strong knowledge and application of regulatory guidelines and standards for highly regulated environments, including GxP validation methodologies, quality management standards (e.g., ISO-27001, ISO-9001), and GAMP 5 & regulatory compliance (FDA, EMA, etc.).
  • Expertise in both agile and waterfall validation strategies, including lean validation methods.
  • Experience with business mapping and process modeling.
  • Proficient in project management practices, with the ability to manage complex, cross-functional projects.
  • Exceptional problem-solving skills with attention to detail and the ability to resolve complex issues effectively.
  • Proficiency in relevant software tools and systems used in validation processes.
  • Demonstrated experience in identifying, assessing, and mitigating risks.
  • Excellent communication skills, including the ability to engage and collaborate with both technical and business stakeholders. Strong presentation skills, capable of organizing and leading workshops.
  • A dedicated team player, skilled at working cross-functionally and collaborating with international teams to drive project success.
  • Fluent in English (written and spoken) is a must. Fluent in German (written and spoken) is a significant advantage.