Quality & Compliance
Specialist II, Supplier Quality
Office Location: Verona, WI
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical 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
The purpose of this position is to provide quality assurance support for the Supplier Quality Management program. This person supports the qualification, monitoring, and ongoing oversight of suppliers, contract manufacturers, and service providers to ensure compliance with company quality standards and applicable global GxP regulations. This role plays a key part in maintaining supplier compliance and managing quality events related to externally sourced materials and services used in pharmaceutical development and commercialization. This person will be expected to interact with internal departments as well as multiple contract organizations to support ongoing pre-clinical and clinical development as well as commercial programs at Arrowhead Pharmaceuticals, Inc.
Responsibilities
- Support supplier qualification, requalification, and ongoing monitoring activities for raw material suppliers, CMOs, contract laboratories, packaging vendors, and service providers.
- Assist with supplier risk assessments and ensure documentation is current and compliant.
- Collaborate with stakeholders and suppliers, as needed, on quality events and non-conformances and issue supplier corrective action requests, as outlined in the applicable quality agreements
- Assist with maintenance of approved supplier lists and supplier quality records.
- Review and assess supplier change notifications for quality and regulatory impact.
- Ensure timely and accurate documentation within the Quality Management System (QMS).
- Track and trend supplier performance metrics (e.g., deviations, on-time CAPA closure, audit findings).
- Identify recurring issues and support continuous improvement initiatives.
- Assist with preparation, update, review, and routing of Arrowhead procedural documents.
- Assist with other QA duties as needed.
Requirements
- BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry is preferred
- 3 years of quality assurance experience in a biotech or pharmaceutical development, manufacturing, or contract manufacturing organization with an emphasis on Supplier Quality.
- Working knowledge of 21 CFR Parts 210/211, ICH Q7, and applicable global regulatory expectations (e.g., FDA, EMA, Health Canada), along with familiarity with relevant regulatory guidance documents.
Preferred:
- Prior experience with use of an electronic document management system in a regulated environment.
- Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office programs, and Smartsheet.
- Excellent interpersonal, verbal, and written communication skills.
- Ability to consistently communicate with external parties in a professional manner.
- Ability to follow company procedures, work instructions, and policies.
- Excellent attention to detail and organizational skills.
- Ability to work independently with minimal supervision as well as manage priorities within a face-paced environment.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.