Director, Quality Data Governance & AI Validation

Scorpion Therapeutics; United States; Hybrid; USD 180,000 - 280,000; Full time

Job summary

Scorpion Therapeutics seeks a senior leader to drive the CSV program across biotech operations, leading Quality Engineers and ensuring data integrity with governance by design. You will evolve methodologies, implement data governance, and align activities with a risk-based SDLC.

Partner with Compliance, IT, and Manufacturing to prepare for inspections, report KPIs, and push AI-enabled validation while fostering continuous improvement and responsible AI deployment.

Qualifications

• Bachelor’s or advanced degree in Data Science, CS, Engineering (Chemical Engineering/Biotech or related), or Life Sciences.
• 15+ years in biotech/pharma/medical device or similarly regulated industry; 8+ years management experience.
• Extensive GMP/GDP knowledge; strong CSV, data integrity, and data governance expertise.
• Demonstrated use of data/analytics/digital tools to improve quality outcomes; AI-enabled solution experience is a strong plus.
• Strong leadership, stakeholder management, matrix leadership, and ability to present data to senior management/inspectors.

Responsibilities

• Lead and direct CSV program for enterprise software validation.
• Improve CSV methodologies and lifecycle approach including AI-enabled validation.
• Define global CSV KPIs and report compliance issues.
• Partner with Compliance on inspections and respond to observations.
• Develop, implement, and communicate quality policies and procedures; collaborate across functions.
• Lead and develop the Quality team.

Skills

Leadership

Data Analytics

Stakeholder Management

Communication to Executives

Process Improvement

Education

Bachelor’s or advanced degree in Data Science/CS/Engineering/Life Sciences

Job description

Scorpion Therapeutics seeks a senior leader to drive the CSV program across biotech operations, leading Quality Engineers and ensuring data integrity with governance by design. You will evolve methodologies, implement data governance, and align activities with a risk-based SDLC.

Partner with Compliance, IT, and Manufacturing to prepare for inspections, report KPIs, and push AI-enabled validation while fostering continuous improvement and responsible AI deployment.