Lead Life Sciences Advisor

vor 4 Wochen

Berlin, Berlin, Deutschland Johnson & Johnson Vollzeit

Position Overview

We are in search of a passionate and experienced Lead Life Sciences Advisor to join our esteemed team at Johnson & Johnson. This role is pivotal in providing expert guidance in the realm of Computer System Validation (CSV) and Artificial Intelligence (AI) solutions within the life sciences sector.

About Us

Johnson & Johnson is a global leader in the healthcare industry, dedicated to improving the health and well-being of people around the world. Our commitment to innovation and quality drives us to seek out the best talent to help us maintain our position at the forefront of the industry.

Key Responsibilities

  • Deliver expert consultation services to clients in the pharmaceutical sector, focusing on computer system validation and AI technologies.
  • Design, implement, and sustain AI solutions utilizing advanced technologies.
  • Integrate internal documentation into AI systems, ensuring accurate source identification.
  • Provide insights on regulatory variances across different regions, presenting findings through clear reports and visual aids.
  • Develop and execute validation deliverables, including compliance plans, test protocols, and validation reports.
  • Review and endorse system tests, user acceptance test scripts, and design specifications.
  • Formulate and comprehend test plans and procedures for AI solutions.
  • Oversee validation processes, conducting timely reviews and escalating issues to management as necessary.

Qualifications

Education

  • Bachelor's degree in Computer Science, Data Science, or a related discipline.
  • A Master's degree is preferred.

Language Proficiency

  • Fluency in English (both oral and written) is essential.
  • Proficiency in additional languages is advantageous.

Experience

  • Minimum of 3 years in Computer System Validation.
  • At least 2 years of experience with the System Development Lifecycle.
  • Prior experience in the Pharmaceutical, Biotechnology, or Medical Device sectors.
  • Familiarity with regulatory standards and guidelines.
  • Understanding of GxP standards and risk-based validation methodologies.

Skills

  • Experience in regulated environments with a solid grasp of GxP standards.
  • Proficient knowledge of industry standards and FDA guidance.
  • In-depth understanding and practical experience with AI technologies.
  • Proven ability to develop testing strategies for AI systems.
  • Strong communication skills, both written and verbal.
  • Ability to work collaboratively in a team or independently.
  • Exceptional attention to detail and commitment to data accuracy.
  • Capability to manage multiple projects and work with remote teams.
  • Strong organizational and multitasking abilities.

What We Offer

  • A collaborative work environment with flat hierarchies.
  • A culture that values diversity and inclusion.
  • Engagement in global projects within a multinational context.
  • Flexible working arrangements and opportunities for remote work.
  • Professional development and training opportunities.
  • Competitive salary and comprehensive benefits package.

If you possess the requisite experience and are eager to contribute to a dynamic team, we encourage you to consider this opportunity with Johnson & Johnson.

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