Lead Specialist, Quality, Digital

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.