Lead Specialist, Quality, Digital

Scorpion Therapeutics; Chicago (IL); On-site; USD 120,000 - 160,000; Full time

Job summary

Scorpion Therapeutics seeks a Lead Digital Quality specialist to provide quality oversight for software, cloud solutions, and digital platforms in biopharma. This role focuses on regulated non-medical-device software used in healthcare and digital health, guiding quality practices across the product lifecycle.

You will collaborate with Product, Engineering, Regulatory, Cybersecurity, and Data teams to develop quality procedures, automate processes, and ensure compliance with evolving ISO, IEC,

Qualifications

• Bachelor's degree in Engineering, CS, Life Sciences or 10+ years relevant experience.
• 6+ years in software quality, engineering, or regulatory compliance.
• Experience with Agile, DevSecOps, and software lifecycle principles.

Responsibilities

• Guide quality practices across product lifecycle: requirements, design, verification, validation, release, change management.
• Review documentation.
• Support risk management, cybersecurity, and compliance.
• Develop procedures and automate processes.
• Train cross-functional teams.
• Monitor quality metrics.
• Support audits and investigations.
• Ensure adherence to evolving standards like ISO 13485, IEC 62304, and FDA software guidance.

Skills

Agile methodologies

DevSecOps

Technical writing

Problem solving

Quality mindset

Cross-functional collaboration

Education

Bachelor's degree in Engineering/CS/Life Sciences

Job description

Role

Lead Digital Quality specialist providing quality oversight for software, cloud solutions, and digital platforms within biopharma, particularly supporting regulated non-medical-device software used in healthcare and digital health.

Responsibilities

• guide quality practices across product lifecycle stages—requirements, design, verification, validation, release, and change management
• review documentation
• support risk management, cybersecurity, and compliance
• develop procedures and automate processes
• train cross-functional teams
• monitor quality metrics
• support audits and investigations
• ensure adherence to evolving standards like ISO 13485, IEC 62304, and FDA software guidance

Requirements

• Bachelor's in Engineering, CS, or Life Sciences (or 10+ years relevant experience)
• 6+ years in software quality, engineering, or regulatory compliance
• experience with Agile, DevSecOps, and software lifecycle principles
• strong technical writing and problem-solving skills

Preferred

• experience in medical device or healthcare tech, cloud-native applications, SaaS, APIs, AI/ML software, and developing quality processes

High Value

• focus on digital health, cloud-based solutions, AI/ML, regulatory compliance, risk management, and software development in regulated environments

Collaboration

Collaboration with Product, Engineering, Regulatory, Cybersecurity, and Data teams; reporting line not specified.

Work Setup

WorkSetup: not specified; no travel requirement stated.