Senior Supplier Quality Specialist - GxP & Audits

Arrowhead Pharmaceuticals, Inc.

San Diego (CA)

On-site

USD 125,000 - 160,000

Full time

45 hours ago
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Job summary

Arrowhead Pharmaceuticals, Inc. in San Diego seeks a qualified professional to lead supplier intake and qualification within the Supplier Quality program. You will assess risk, approve qualification records, and manage audit assets in Veeva QMS, reporting to the Sr. Manager, Supplier Quality, and supporting CAPAs as needed.

The role requires 5 years of pharma quality experience, strong GxP knowledge, and hands-on Veeva QMS usage to drive supplier oversight and regulatory readiness.

Qualifications

  • Bachelor's degree in a scientific, technical, or related field or equivalent experience.
  • 5 years of quality assurance in pharma/biotech with 4+ years in supplier quality or GxP auditing.
  • Strong knowledge of GMP/GLP/GDP/GCP/GVP and related regulatory guidelines.
  • Experience reviewing supplier qualification records and audit reports.
  • Hands-on use of Veeva QMS for audit documentation and approvals.

Responsibilities

  • Manage end-to-end supplier intake and initial risk assessment per GxP.
  • Review and approve supplier qualification records and risk assessments.
  • Review supplier audit reports in Veeva QMS and ensure CAPA closure.
  • Lead or support supplier requalification and risk-based decisions.
  • Maintain and improve supplier intake, qualification, and qualification metrics.
  • Coordinate audits with auditors and business owners, track status to completion.
  • Support health authority inspections and internal audits related to supplier quality.

Skills

GxP compliance
Audit report review
Supplier quality oversight
Risk assessment

Education

Bachelor's degree in Life Sciences or related field

Tools

Veeva QMS

Job description

Arrowhead Pharmaceuticals, Inc. in San Diego seeks a qualified professional to lead supplier intake and qualification within the Supplier Quality program. You will assess risk, approve qualification records, and manage audit assets in Veeva QMS, reporting to the Sr. Manager, Supplier Quality, and supporting CAPAs as needed.

The role requires 5 years of pharma quality experience, strong GxP knowledge, and hands-on Veeva QMS usage to drive supplier oversight and regulatory readiness.

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