Lead, Clinical Quality Documents & eQMS

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

Job summary

Scorpion Therapeutics is seeking a dedicated Document Management Lead for Clinical Development to own the end-to-end lifecycle of controlled documents within the eQMS, ensuring compliance and timely delivery. You will partner with Clinical Ops, QA, Regulatory Affairs, and other functions to manage workflows, audits, and inspections, maintain metadata and document integrity, and drive process improvements.

This role is in California with in-office requirements and 5+ years in pharma/biotech

Qualifications

• BS/BA in a scientific field (chemistry, biology, biochemistry, etc.).
• Minimum 5 years’ pharma/biotech, clinical quality assurance, or CRO document writing/maintenance.
• Working knowledge of GCP, GVP and/or GLP.
• Ability to follow company procedures and policies; strong attention to detail.
• Ability to multi-task/prioritize with minimal supervision.
• Excellent interpersonal, verbal, and written communication.

Responsibilities

• Lead the end-to-end lifecycle of controlled clinical documents (SOPs, work instructions, templates, forms) within the eQMS.
• Support QA in executing document control workflows (development, review, revision, approval, issuance, periodic review, retirement).
• Coordinate document activities with cross-functional stakeholders (Clinical Operations, Drug Safety/Pharmacovigilance, Biometrics, Clinical Data Management, Regulatory Affairs, Medical Writing, Clinical Supply Management, Clinical Quality Assurance).
• Facilitate cross-functional document review/approval workflows by coordinating authors, reviewers, approvers, and QA partners.
• Ensure documents remain current and aligned with regulatory requirements (ICH, GCP, GVP) and company policies.

Skills

Document management

QA coordination

Cross-functional coordination

Attention to detail

Communication

Education

BS/BA in a scientific field

Tools

Adobe Acrobat

Microsoft Word

Excel

Smartsheet

Job description

Scorpion Therapeutics is seeking a dedicated Document Management Lead for Clinical Development to own the end-to-end lifecycle of controlled documents within the eQMS, ensuring compliance and timely delivery. You will partner with Clinical Ops, QA, Regulatory Affairs, and other functions to manage workflows, audits, and inspections, maintain metadata and document integrity, and drive process improvements.

This role is in California with in-office requirements and 5+ years in pharma/biotech