Hiring.Camp

Human Factors Lead (Fixed-Term)

Alvotech

·

Yesterday

Location
Stockholm Office, Sweden · Reykjavik Headquarters
Workplace
Remote
Type
Full-time
Seniority
Lead
Education
Master
Closing date
Today
Source
Workday

Description

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.

Skills

FDA

Similar Jobs

2

Human Factors Engineering (HFE) Lead - Associate Engineering Fellow (AEF)

Takeda is an industry·USA - MA - Lexington, US

3mo ago

Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Factors

Takeda is an industry·USA - MA - Cambridge, US

4mo ago