Senior QA Specialist, Global Document Control Management

Scorpion Therapeutics; California (MO); On-site; USD 90,000 - 130,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior Quality Assurance specialist to develop, implement, and maintain the global GxP Document Management Program for a late-stage oncology biotech.

The role covers document workflows, Change Controls, and serving as SME for Veeva QualitySuite, while supporting SOPs, training, audits, and inspection readiness across global operations.

Qualifications

• BA/BS in Biological Sciences or related field.
• 5+ years of QA experience in GxP environments within Pharma/Biotech.
• Proficient with GxP standards, regulatory guidelines, and Veeva platforms.

Responsibilities

• Managing document workflows and Change Controls.
• Serving as SME for electronic Document Management Systems (Veeva QualitySuite).
• Supporting global SOPs, training, audits, and inspection readiness.

Skills

GxP QA experience

Veeva platforms

Regulatory guidelines

Education

BA/BS in Biological Sciences or related field

Tools

Veeva QualitySuite

Job description

Role

Senior Quality Assurance specialist responsible for developing, implementing, and maintaining the global GxP Document Management Program within a late-stage oncology biotech focusing on RAS-targeted therapies.

Responsibilities

Responsibilities include managing document workflows, coordinating Change Controls, serving as SME for electronic Document Management Systems (Veeva QualitySuite), and supporting global SOPs, training, audits, and inspection readiness.

Qualifications

Qualifications: BA/BS in Biological Sciences or related field; 5+ years of QA experience in GxP environments within Pharma/Biotech; proficient with GxP standards, Veeva platforms, and regulatory guidelines.

Preferred

Preferred: strategic project management skills, experience with regulatory inspections, continuous improvement mindset, and global organization experience.

High Value

HighValue: GxP quality systems, document lifecycle management, Veeva QualitySuite, global quality governance, and audit support.

Work Setup

WorkSetup: not specified.