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
The purpose of the Specialist III, Quality Assurance position is to provide Quality Assurance support for Arrowhead Pharmaceuticals’ raw materials program. As a member of the Supplier Quality team, this role supports raw material supplier qualification, material risk assessment, specification development, and change control activities to ensure compliance with GMP and applicable regulatory requirements. The position also assists with the collection, analysis, and generation of supplier performance metrics to support ongoing monitoring and continuous improvement. This role requires regular interaction with internal cross-functional stakeholders as well as external organizations to support pre-clinical, clinical, and commercial manufacturing programs
Responsibilities
- Assist with raw material lifecycle management including, but not limited to, drafting, editing, reviewing, and approving raw material specifications, reviewing raw material qualification protocols and reports, and ensuring compliance with periodic requalification cycles, in collaboration with internal functional teams
- Perform risk assessments for raw materials (e.g., impact to product quality, patient safety, and regulatory compliance).
- Advise Supplier Quality Audits team with supplier qualification and requalification as needed
- Support maintenance of the ASL by providing and entering qualification information into the eQMS
- Collaborate with raw material suppliers to resolve quality issues, documentation discrepancies, and non-conformances per internal procedures.
- Review Supplier Change Notifications and assess impact on product quality.
- Initiate and manage change controls related to raw materials
- Manage Supplier Corrective Action Requests (SCARs) per internal procedures and applicable quality agreements.
- Support deviation investigations, CAPAs, and root cause analyses involving material issues.
- Provide quality oversight during material onboarding and lifecycle management
- Request and review supporting documentation for raw material qualifications from suppliers including, but not limited to, production records, certificates of analysis (CoA), certificates of conformance (CoC), BSE/TSE statements, etc.
- Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval.
- Assist with the preparation, update, review, and routing of Arrowhead procedural documents.
- Track and trend raw material-related quality metrics
- Assist with other QA duties as needed.
Requirements
- BS/BA in Chemistry, Biology, Biochemistry, or related scientific field is preferred.
- Minimum of 5+ years of Quality Assurance experience in a GMP-regulated biotech or pharmaceutical manufacturing environment, with an emphasis on raw material release, Supplier Quality, and/or material qualification activities.
- 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 (EDMS) in a regulated environment.
- Prior experience with use of an Enterprise Resource Planning (ERP) software in a regulated environment.
- Working knowledge of ICH Q3, Q8, Q9, Q10, and Q11.
- Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office applications, 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 managing priorities within a face-paced environment.
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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Skills Required
- Minimum of 5+ years of Quality Assurance experience in a GMP-regulated biotech or pharmaceutical manufacturing environment, with emphasis on raw material release, Supplier Quality, and material qualification activities.
- Working knowledge of 21 CFR Parts 210/211, ICH Q7, and applicable global regulatory expectations (e.g., FDA, EMA, Health Canada).
- Candidates must have current, valid authorization to work in the country where this role is located.
- BS/BA in Chemistry, Biology, Biochemistry, or related scientific field.
- Prior experience with use of an Electronic Document Management System (EDMS) in a regulated environment.
- Prior experience with use of an Enterprise Resource Planning (ERP) software in a regulated environment.
- Working knowledge of ICH Q3, Q8, Q9, Q10, and Q11.
- Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office applications, and SmartSheet.
- Excellent interpersonal, verbal, and written communication skills and ability to communicate professionally with external parties.
- Ability to follow company procedures, work instructions, and policies; strong attention to detail and organizational skills; ability to work independently with minimal supervision.
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.
