CSV Lead: Hybrid GxP Systems Validation & AI

Scorpion Therapeutics; United States; Hybrid; USD 110,000 - 126,000; Full time

Benefits offered by this job

Hybrid work (60% office/40% home)

Onsite in Waltham, MA 3 days/week

Annual performance bonus

Job summary

Scorpion Therapeutics seeks an experienced CSV leader to support validation across Quality, Regulatory, and R&D systems in a GxP environment. You will represent CSV in cross-functional teams and drive risk-based validation using GAMP 5 and Quality Risk Management.

You will develop and maintain validation documentation, conduct risk assessments, and communicate outcomes to auditors. Hybrid work with on-site presence in the US is offered.

Qualifications

• Bachelor’s or Master’s in a relevant field with extensive GxP validation experience (9+ years or 7+ years with Master’s).
• Proven CSV experience in a GxP environment; quality systems, compliance, and data integrity expertise.
• Knowledge of GxP regulations (21 CFR Part 11/312/314, ICH Q7/Q8/Q9/Q10).
• Strong leadership, collaboration, written/verbal communication, and time management; ability to work cross-functionally.

Responsibilities

• Support computer system validation (CSV) across Quality, Regulatory, and R&D systems in a compliant manner.
• Represent CSV in project teams and track progress with stakeholders.
• Apply risk-based validation using GAMP 5 and Quality Risk Management.
• Develop, review, approve, and execute validation documentation across the system lifecycle.
• Conduct/approve risk assessments per Quality Risk Management policy.
• Communicate validation outcomes to reviewers/auditors.
• Maintain GxP compliance through monitoring, validation, and system lifecycle activities.
• Create/maintain CSV templates in ValGenesis and related job aids.
• Support regulatory inspections, internal audits, and third-party audits.

Skills

Leadership

Cross-functional collaboration

Communication

Time management

Education

Bachelor’s in computer science, Life Sciences, Engineering, or related field

Master’s degree in related field

Tools

LMS

Veeva DMS

TrackWise

ValGenesis

Job description

Scorpion Therapeutics seeks an experienced CSV leader to support validation across Quality, Regulatory, and R&D systems in a GxP environment. You will represent CSV in cross-functional teams and drive risk-based validation using GAMP 5 and Quality Risk Management.

You will develop and maintain validation documentation, conduct risk assessments, and communicate outcomes to auditors. Hybrid work with on-site presence in the US is offered.