Senior Clinical Quality Documentation Manager

Arrowhead Pharmaceuticals

San Diego (CA)

On-site

USD 95,000 - 130,000

Full time

14 days+

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Job summary

Arrowhead Pharmaceuticals, Inc. is seeking a Clinical Quality System Document Manager to oversee the documentation lifecycle in the eQMS, ensuring SOPs and related documents stay current with ICH, GCP, and regulatory expectations.

The role partners with QA and Clinical Development to support inspection readiness and continuous improvement. The position is based in Pasadena or San Diego, requiring in-office presence five days a week, and involves implementing new document management capabilities

Qualifications

5+ years in pharmaceutical/biotech clinical quality assurance writing and documents
Working knowledge of GCP, GVP and/or GLP
Ability to follow procedures, instructions, and policies
Excellent attention to detail and organization
Strong verbal and written communication skills

Responsibilities

Lead end-to-end document lifecycle for SOPs, work instructions, templates and forms in eQMS
Coordinate development, review, approval, issuance, and retirement of controlled documents
Collaborate with Clinical Development and QA to ensure regulatory alignment
Monitor document status, reviews, timelines, and KPIs for inspection readiness
Support audits and change controls related to the Clinical Quality Management System