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 supports Supplier Quality Assurance with activities related to supplier qualification and Approved Supplier Management. Responsibilities include initial supplier risk assessment, Approved Supplier List Periodic Review, and supplier audit support and coordination. The Supplier Quality Specialist II will collaborate with Arrowhead business teams, the Supplier Quality Assurance team, and internal and external auditors.
Responsibilities
- Assist in Supplier GxP-relevance assessment
- Manage initial risk assessment of new regulated suppliers from the business teams
- Audit Coordination and administrative support
- Lead periodic review efforts of the Approved Suppliers List
- Maintain supplier, audit, and qualification records within Veeva
- Support Lead Auditors by tracking timelines and preparing required documentation
- Oversee contract auditors conducting supplier audits on Arrowhead’s behalf
- Maintain supplier licenses, certifications, and related compliance documentation within Veeva
- Generate and distribute supplier metrics to QA groups and business stakeholders
- Support Arrowhead audits and inspections
- Assist with preparation, update, review, and routing of Arrowhead procedural documents
- Support eQMS and other system implementations.
- Perform additional QA duties as needed.
Requirements
- Associate’s degree required, with BS/BA preferred.
- Minimum of three years of quality assurance experience, preferably in a biotech or pharmaceutical development, manufacturing, or contract manufacturing organization.
- Knowledge of applicable regulations including GxP (GMP, GCP, GLP, GVP)
- Ability to follow company procedures, work instructions, and policies.
- Competent knowledge of and ability to use Microsoft Word, Outlook, PowerPoint and Excel.
- Excellent attention to detail and organizational skills.
- Ability to multi-task and prioritize work with minimal supervision.
- Excellent interpersonal, verbal, and written communication skills.
Preferred
- Prior experience with use of an electronic document management system in a regulated environment (Veeva).
- Supplier Management experience either in QA or on the business side
- Database management or software implementation experience
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.
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Top Skills
What We Do
Arrowhead Pharmaceuticals is a clinical stage, Nasdaq listed (ticker ARWR) company developing medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, our 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. Our RNAi-based therapeutics are at the leading edge of genetic-based therapy with the potential to bring life changing treatments for patients. Our Targeted RNAi Molecule (TRiMTM) platform utilizes ligand-mediated delivery and is designed to enable tissue-specific targeting while being structurally simple. The TRiM platform builds on more than a decade of work on actively targeted drug delivery and offers several advantages including simplified manufacturing and reduced costs; multiple routes of administration; and potential for improved safety. Our employees are nimble, science-driven, and innovative professionals. A career at Arrowhead offers the opportunity to collaborate with top notch scientists to rapidly discover and develop RNAi-based therapeutics to add to our growing pipeline. Research and development activities are located in Madison, WI. Our R&D group includes fully-integrated capabilities for chemistry, biology, and toxicology. Madison is an exciting and sophisticated city that includes state government, the flagship campus of the University of Wisconsin, and major research organizations. Our HQ, clinical and regulatory operations are located in Pasadena, CA. Just north of Los Angeles and resting in the foothills of the San Gabriel Mountains, Pasadena is known for its natural scenic beauty, vibrant cultural and academic environment and rich architectural setting.
