Validation Leadership Manager

Há 6 dias

Lisboa, Lisboa, Portugal Buscojobs Portugal Tempo inteiro

About the Role

We are seeking a seasoned Validation Manager to spearhead validation activities across various project settings, encompassing SAP implementation, upgrade, or enhancement to transformational projects. This role will cover qualification activities, computer system validation, process validation, and ensuring compliance with regulatory standards.

As the Validation Manager, you will be responsible for ensuring that all project deliverables meet the highest quality standards and comply with regulatory guidelines throughout the project lifecycle. You will work closely with cross-functional teams, including stakeholders from business, quality assurance, and IT experts to align validation strategies with project objectives and timelines.

The ideal candidate will bring a deep understanding of validation processes, strong leadership skills, and the ability to navigate complex project environments. Your role will be pivotal in driving successful project outcomes while maintaining regulatory compliance and ensuring lasting validation excellence.

Key Responsibilities

  • Develop, refine, 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.
  • Ensure all validation documentation – system lifecycle documents, change controls, reports, and other protocols – are comprehensive, accurate, and fully compliant with regulatory standards/company policies following good documentation practice.
  • Provide support for testing activities to guarantee adherence to quality standards and regulatory requirements.
  • Conduct risk assessments to identify validation-related risks and formulate effective mitigation plans.
  • Apply a risk-based approach to prioritize validation of critical systems and processes.
  • Serve as the subject matter expert for validation during regulatory audits and inspections, offering expert guidance and assurance.
  • Regularly assess and optimize validation processes to identify opportunities for improvement and integrate industry best practices.
  • Act as the first point of contact for managing critical incidents, deviations, and CAPA (corrective and preventive action) processes.
  • Ensure rigorous management of compliance aspects throughout the project lifecycle, while maintaining close communication with key stakeholders.
  • Provide ongoing compliance guidance and deliver training to team members to ensure consistent regulatory adherence.
  • Strongly seek improvement for test management, document management, and change control management activities.
  • Lead and mentor your team on validation methodologies, principles, and best practices.
  • Cultivate a culture of continuous improvement and ensure that compliance is embedded and plays a pivotal role within the validation team's daily operations as well as in the wider project context.

Qualifications

  • Bachelor's or master's degree (BSc, MBA, MSc) in natural sciences, information technology, engineering, pharmacy, or any 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 (pharmaceuticals or life sciences), including in-depth understanding of 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 modelling.
  • 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.
  • 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.

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