Manager, Clinical Quality System Documents

Scorpion Therapeutics; San Diego (CA); On-site; USD 120,000 - 145,000; Full time

Job summary

Scorpion Therapeutics is seeking a Clinical Quality System Document Manager in Pasadena or San Diego, CA, working in office 5 days/week. You will oversee clinical quality documents in the eQMS (Veeva), manage the full document lifecycle, and ensure regulatory alignment across Clinical Development.

The role requires 5+ years in pharma/biotech or CRO document writing/maintenance, with strong knowledge of GCP/GVP/GLP, and proven attention to detail, organization, and communication.

Qualifications

• BS/BA in a scientific field (e.g., chemistry, biology, biochemistry).
• 5+ years in pharma/biotech, clinical quality assurance, or CRO document writing/maintenance.
• Working knowledge of GCP, GVP and/or GLP.
• Ability to follow company procedures/policies.
• Strong attention to detail, organization, prioritization, and communication.

Responsibilities

• Manage, maintain, and oversee clinical quality documents in the eQMS; ensure accuracy, currency, and compliance with regulatory/industry/company requirements.
• Coordinate end-to-end lifecycle of controlled documents (SOPs, work instructions, templates, forms) including development, review, revision, approval, issuance, periodic review, and retirement.
• Facilitate cross-functional document review workflows and monitor document status, timelines, and metrics; escalations overdue items.
• Partner with QMS Quality Assurance to ensure harmonization and consistency across Clinical Development functions.
• Provide guidance to document authors/reviewers on standards, formatting, version control, and regulatory expectations.
• Support inspection readiness (internal, regulatory, and third-party) by ensuring documentation is complete, audit-ready, and retrievable.
• Develop/maintain document control procedures and contribute to continuous improvement of document management processes and eQMS (Veeva) enhancements/change controls.

Skills

Document control

Regulatory compliance

GCP knowledge

GVP knowledge

GLP knowledge

Attention to detail

Organization

Communication

Education

BS/BA in a scientific field

Tools

Veeva eQMS

Adobe Acrobat

Microsoft Word

Microsoft Excel

Smartsheet

Job description

Clinical Quality System Document Manager (Pasadena or San Diego, CA; in office 5 days/week)

Responsibilities

• Manage, maintain, and oversee clinical quality documents in the eQMS; ensure accuracy, currency, and compliance with regulatory/industry/company requirements.
• Coordinate end-to-end lifecycle of controlled documents (SOPs, work instructions, templates, forms) including development, review, revision, approval, issuance, periodic review, and retirement.
• Facilitate cross-functional document review workflows and monitor document status, timelines, and metrics; escalations overdue items.
• Partner with QMS Quality Assurance to ensure harmonization and consistency across Clinical Development functions.
• Provide guidance to document authors/reviewers on standards, formatting, version control, and regulatory expectations.
• Support inspection readiness (internal, regulatory, and third-party) by ensuring documentation is complete, audit-ready, and retrievable.
• Develop/maintain document control procedures and contribute to continuous improvement of document management processes and eQMS (Veeva) enhancements/change controls.

Requirements

• BS/BA in a scientific field (e.g., chemistry, biology, biochemistry).
• 5+ years in pharma/biotech, clinical quality assurance, or CRO document writing/maintenance.
• Working knowledge of GCP, GVP and/or GLP.
• Ability to follow company procedures/policies.
• Strong attention to detail, organization, prioritization, and communication.

Preferred

• Experience with electronic document management systems in regulated environments.
• Proficiency with Adobe Acrobat, Microsoft Word/Excel, and Smartsheet.

Pay range

• $120,000-$145,000 USD.