Director, Digital Quality & Intelligence

Scorpion Therapeutics; Frederick (CO); Hybrid; USD 180,000 - 280,000; Full time

Job summary

Scorpion Therapeutics seeks a senior leader to oversee digital quality and intelligence within Global Quality Management Systems, focusing on quality analytics, automation, AI, and digital transformation.

The role leads a global team of data scientists, analysts, and developers, establishes governance for AI/automation, and drives a compliant, scalable digital quality program across regulatory functions in biopharma. Occasional travel and day shift in Colorado map to our operations.

Qualifications

• 10+ years in life sciences with managerial experience.
• 5+ years managing global analytics/automation/digital quality teams.
• Proven QMS experience, process harmonization, regulated environments.
• Strong portfolio and project management skills.
• Working knowledge of analytics platforms, cloud, AI, and regulatory data governance.

Responsibilities

• Develop and execute a risk-based QMS strategy for global quality and regulatory functions.
• Lead a global team of data scientists, analysts, and developers.
• Establish governance and lifecycle controls for AI/automation tools.
• Manage portfolio and cross-functional projects ensuring inspection readiness.
• Promote adoption and responsible use of digital quality capabilities.
• Monitor industry trends to inform strategy.
• Advise GQ leadership on advanced data science and automation initiatives.

Skills

Data analytics leadership

AI & automation

QMS expertise

Regulatory compliance

Project management

Cross-functional leadership

Cloud platforms

Governance

Education

Bachelor's degree in quantitative/scientific field

Advanced degree (MS/PhD)

Tools

Jira

Power Automate

Job description

Role:

Senior leader overseeing digital quality and intelligence within Global Quality Management Systems, focusing on quality analytics, automation, AI, and digital transformation.

Responsibilities:

• develop and execute a risk-based QMS strategy for global quality and regulatory functions, translating complex needs into scalable digital solutions
• lead a global team of data scientists, analysts, and developers
• establish governance and lifecycle controls for AI/automation tools
• manage portfolio and cross-functional projects, ensuring alignment with regulatory standards and inspection readiness
• promote adoption and responsible use of digital quality capabilities
• monitor industry trends to inform strategy
• advise GQ leadership on advanced data science and automation initiatives

Requirements:

1. bachelor’s degree in a quantitative/scientific field
2. 10+ years in life sciences with managerial experience
3. 5+ years managing global teams in analytics, automation, or digital quality within biopharma, medical device, or diagnostics
4. proven experience in QMS, process harmonization, and regulated environments
5. strong portfolio and project management skills
6. working knowledge of analytics platforms, cloud environments, AI, and regulated data governance

Preferred:

• advanced degree
• expertise in AI/machine learning
• FDA 21 CFR Part 11
• experience with lifecycle management tools like Jira or Power Automate

HighValue:

• biopharma/regulatory
• digital quality
• AI
• automation
• GxP
• global scope
• cross-functional leadership
• occasional travel
• day shift
• full-time

Reporting to AVP of QMS, leading a strategic, innovative, and compliance-driven digital quality organization.