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Alvotech

Human Factors Lead (Fixed-Term)

Posted 2 hours ago
5-10 years experience
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AI Summary

The Human Factors Lead will oversee the strategy, development, and execution of human factors activities across the product portfolio. This includes directing design validation, managing technical documentation, and providing expert guidance to internal stakeholders.

About the role:

Join our Combination Products and Devices department as interim Lead of Human Factors until mid-March 2027, and lead the strategy, development, and execution of human factors activities across our product portfolio. Based in Stockholm or Reykjavík, you will lead a team of specialists and oversee design validation, human factors studies, expert reviews, technical documentation, and regulatory deliverables. This role is an opportunity to shape processes, standards, and strategy in a complex, regulated environment.



Key Responsibilities:

  • Own design validation and human factors strategy across the product portfolio. 
  • Direct and provide human factors input to projects, including expert reviews and technical memoranda. 
  • Authors and oversees primary user analyses, design validation plans, protocols and reports, and Human Factors Engineering reports. 
  • Lead the planning and execution of human factors studies. 
  • Interpret and adapt policies and guidelines, improve processes, and contribute to drafting SOPs. 
  • Build and maintain subject-matter expertise in human factors and applicable regulations for combination drug products. 
  • Shape organizational standards and ways of working, and contribute to budgeting and resource planning. 
  • Oversee large projects and contribute to strategic and development initiatives. 
  • Address complex, time-sensitive, and non-precedent challenges with sound judgment. 
  • Provide timely expert guidance to internal and local stakeholders. 
  • Contribute industry insight and feedback to the development of FDA guidance. 

 

Job Requirements:

  • Master's degree in a relevant scientific, technical, or business-related field.
  • Minimum of five years of relevant professional experience.
  • Demonstrated ability to drive performance improvements and identify innovative, cost-effective solutions.
  • Strong understanding of industry trends and a proactive approach to staying informed of developments within the field.
  • Ability to foster a collaborative, positive, and high-performing team environment.
  • Strong interpersonal and communication skills, with the ability to build effective partnerships across functions.
  • Entrepreneurial mindset with a passion for innovation and continuous improvement.
  • Leadership experience is considered an advantage.

 

What we offer:

  • Meaningful Work: Tackle inspiring challenges with passionate colleagues on projects that make a real difference in people’s lives.
  • Global Growth: Join a fast-growing, international company with a diverse and inclusive culture.
  • Collaborative Environment: Work in a positive, flexible, and innovative setting that values teamwork and creativity.
  • Career Development: Benefit from support for personal growth, internal mobility, and ongoing training opportunities.
  • Cultural Exchange: Take advantage of exchange opportunities with our Reykjavik, Iceland lab for short or long-term stays.
  • Well-being & Perks: Enjoy wellness benefits, on-site changing rooms, and a stocked office with snacks, fruit, and great coffee.
  • Community & Celebration: Participate in regular social events and celebrate team milestones together.

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