Clinical Quality Documentation Lead (eQMS)

Arrowhead Pharmaceuticals; Los Angeles (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. is seeking a Clinical Quality System Document Manager to oversee the eQMS documentation, ensure accuracy and regulatory compliance, and drive timely update cycles across Clinical Development and QA.

The role requires collaboration with multiple functions, guidance to authors, and support for inspection readiness and change controls within Arrowhead’s quality systems. Based in Pasadena or San Diego, in-office five days a week.

Qualifications

• BS/BA in a scientific field required.
• Minimum 5 years of experience in pharmaceutical/biotech clinical quality assurance or CRO.
• Working knowledge of GCP, GVP and/or GLP regulations.
• Ability to follow procedures, work instructions, and policies.
• Excellent attention to detail and organizational skills.

Responsibilities

• Lead end-to-end lifecycle of controlled clinical documents within the eQMS.
• Coordinate development, review, revision, approval, and retirement of SOPs, templates, and related documents.

Skills

Document management

Regulatory compliance

Quality systems

Cross-functional collaboration

Attention to detail

Education

BS/BA in chemistry, biology, or biochemistry

Tools

Adobe Acrobat

Microsoft Word

Excel

Smartsheet

Job description

Arrowhead Pharmaceuticals, Inc. is seeking a Clinical Quality System Document Manager to oversee the eQMS documentation, ensure accuracy and regulatory compliance, and drive timely update cycles across Clinical Development and QA.

The role requires collaboration with multiple functions, guidance to authors, and support for inspection readiness and change controls within Arrowhead’s quality systems. Based in Pasadena or San Diego, in-office five days a week.