Arrowhead Pharmaceuticals→
Senior Specialist, Supplier Quality at Arrowhead… · Pasadena
Job Description
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
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.
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
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
Preferred
- 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).
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.