Sr. QA Computer System Validation Mgr.

Scorpion Therapeutics; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Scorpion Therapeutics in the United States is seeking a Senior QA Computer System Validation Manager to oversee GxP CSV across biotech environments, supporting late-stage therapeutics including Phase 3 assets for retinal diseases and cystic fibrosis.

You will lead validation lifecycle oversight, review CSV deliverables, manage external vendors, and drive regulatory readiness with FDA/EMA/ICH and GAMP 5 standards, while collaborating cross-functionally and supporting audits.

Qualifications

• Must have hands-on QA oversight of validation lifecycle for GxP computer systems.
• Experience reviewing CSV deliverables across validation activities.
• Proven ability to manage external vendors and oversee qualification activities.

Responsibilities

• Provide QA oversight of the CSV lifecycle.
• Review CSV deliverables and ensuring accuracy.
• Manage external vendor activities to support validation goals.
• Ensure compliance with FDA, EMA, ICH, and GAMP 5 standards.
• Support audits and inspections and coordinate responses.
• Collaborate cross-functionally to improve systems and processes.

Skills

QA oversight

CSV lifecycle management

Vendor management

Regulatory standards compliance

Cross-functional collaboration

Documentation review

Education

Bachelor's degree in life sciences, computer science, or related field

Job description

Role

Senior QA Computer System Validation Manager overseeing GxP computer systems in GCP, GMP, and GLP environments within a biotech company developing late-stage therapeutics, including Phase 3 assets for retinal diseases and cystic fibrosis.

Responsibilities

• provide QA oversight of validation lifecycle
• review CSV deliverables
• manage external vendor activities
• ensure compliance with FDA, EMA, ICH, and GAMP 5 standards
• support audits and inspections
• and collaborate cross-functionally to improve systems and processes

Requirements

• Bachelor's in life sciences, computer science, or related field
• 5-7 years biopharma experience, with at least 4 years in QA CSV supporting clinical trials and validated systems like IRT, EDC, and eTMF
• deep knowledge of 21 CFR Part 11, EU Annex 11, data integrity, and regulatory standards
• strong communication and stakeholder engagement skills

HighValue

supporting clinical systems in late-phase development, compliance with global regulations, validation of critical clinical systems, and cross-functional partnership.

WorkSetup

less than 5% travel; primarily office-based.