Item Alignment Inc

DIRECTOR OF SOFTWARE ENGINEERING – LIFE SCIENCES

Horsham, PA

13 days ago
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Summary

JOIN A GREAT TEAM AS A DIRECTOR OF SOFTWARE ENGINEERING – LIFE SCIENCES

Our mission is to bring clarity to innovation by delivering better outcomes to the innovation community. Every day, we support the development of technologies that advance humanity.

We are seeking a Director of Software Engineering to lead our regulated Life Sciences SaaS platform. You will define technical vision, oversee compliance with industry regulations (GxP, FDA 21 CFR Part 11), manage global teams, and drive best practices in cloud architecture, security, and software development.

Key Responsibilities:

  • Define and execute the technical vision, architecture, and strategy for our Labeling Compliance SaaS platform.
  • Ensure compliance with FDA, EMA, GxP, ISO 27001, and ISO 9001 standards.
  • Implement Agile best practices to drive efficiency and innovation.
  • Recruit, mentor, and scale a high-performing global engineering team.
  • Integrate AI/ML, automation, and cloud technologies into our development processes.
  • Oversee vendor selection, third-party integrations, and architectural decisions.
  • Lead research, design, and development initiatives while providing hands-on technical expertise.
  • Manage system and user acceptance testing to ensure high-quality business solutions.
  • Foster a culture of continuous improvement, accountability, and innovation.

What We’re Looking For:

  • 12+ years of software development experience.
  • 8+ years of software engineering leadership, managing global teams.
  • Strong expertise in .NET/C#, Java, JavaScript, SQL, and XML.
  • Experience building regulated SaaS platforms within Life Sciences.
  • Proven ability to lead software development best practices and drive Agile methodologies.
  • Bachelor's degree in Engineering, Computer Science, or a related field (Advanced degree preferred).
  • Live close to or able to relocate to Pennsylvania and available to go to the office 2 days twice a month (4 days total)

Why Join Us?

  • Be part of a leading global company in innovation and compliance.
  • Work on cutting-edge Life Sciences SaaS solutions.
  • Lead a high-impact, strategic engineering team.

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