Senior Specialist, Supplier Quality

Arrowhead Pharmaceuticals•San Diego, CA

2d•$105,000 - $120,000

About The Position

This position is responsible for supplier intake and qualification activities within Arrowhead's Supplier Quality program, ensuring new and existing suppliers are assessed and qualified in accordance with GxP and other applicable regulations. This position independently reviews and approves supplier qualification records and risk assessments to determine supplier approval status, and reviews and approves audit reports and associated audit records within Veeva Quality Management System (QMS) as part of the qualification process. This position reports to the Sr. Manager, Supplier Quality, and may also support supplier-related quality events, corrective actions, and inspection readiness.

Requirements

Bachelor's degree in a scientific, technical, or related field (e.g., Life Sciences, Chemistry, Pharmacy, Engineering) or equivalent experience
5 years of quality assurance experience in a pharmaceutical or biotechnology quality, with 4+ years in supplier quality, GxP auditing, or quality compliance, including direct experience with supplier/vendor intake, qualification, and risk assessment
Strong knowledge of GMP/GLP/GDP/GCP/GVP and FDA, EU, and ICH guidelines as applicable to supplier and vendor quality oversight
Demonstrated experience independently reviewing and approving supplier qualification records, risk assessments, and audit reports
Hands-on experience using Veeva QMS (or an equivalent electronic quality management system) to review and approve audit reports and audit records

Nice To Haves

Prior GxP auditing, vendor qualification, and/or compliance investigation experience
Prior experience with use of an electronic document management system in a regulated environment (Veeva)
Knowledge of using Artificial Intelligence (AI) and/or building AI models (i.e., training dataset creation, validation, and reassessment).

Responsibilities

Manage the end-to-end supplier intake process for new suppliers including initial risk assessment, categorization, and determination of the appropriate qualification pathway in accordance with GxP requirements
Independently review and approve supplier qualification records and risk assessments to determine and document supplier approval status
Review and approve supplier audit reports and associated audit records within Veeva Quality Management System (QMS) as part of the qualification and requalification process, ensuring findings, responses, and CAPAs are appropriately documented and tracked to closure
Lead or support periodic requalification of existing suppliers per internal procedures and based on risk category, performance history, and audit results
Maintain and continuously improve the supplier intake and qualification program, including risk categorization criteria, the approved supplier list, and requalification schedules
Partner with Supplier Management, Supply and Sourcing Management, and Business teams during intake to gather required documentation and assess supplier-related compliance and quality risks
Coordinate with auditors and business owners to schedule and support qualification audits, and track audit status through to completion
Generate, track, trend, and report supplier intake and qualification metrics (e.g., cycle time, audit status, risk ratings) to the Sr. Manager, Supplier Quality
Support the issuance, review, tracking, and closure of Quality Events (e.g., deviations and CAPAs) related to supplier intake and qualification
Ensure supplier qualification, risk assessment, and audit documentation is properly created, reviewed, and maintained within Veeva electronic repositories (QMS/QualityDocs)
Support health authority inspections and internal audits related to supplier intake and qualification
Participate in the lifecycle of Arrowhead Standard Operating Procedures and Work Instructions related to supplier qualification, GxP, and applicable global regulations
Keep up to date with relevant quality legislation and regulatory expectations; help translate changes into corporate policies and procedures
Other duties consistent with the position as assigned from time to time