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 Information Systems & Informatics Quality Systems Manager is responsible for the ownership, oversight, and continuous improvement of enterprise Quality Systems and associated systems that support regulated business processes. This role ensures that Quality Systems are compliant, validated, and effectively support the business. The position serves as key liaison between IS&I and Quality, with a strong focus on Business process & configured system effectivity, continuous improvement, regulatory compliance, system lifecycle management, and audit readiness.
Responsibilities
- System Owner - manage electronic QMS and processes, including Change Control, Deviations, CAPAs, SCARs, Audits, Findings, Suppliers, Complaints Management, Batch Release Management, Document Management, Training, etc.
- Ensure systems align with established Quality System procedures and business process requirements.
- Identify and lead continuous improvement initiatives to enhance system usability, compliance, and efficiency.
- CSA.CSV expertise
- Regulatory Applicability Assessments/Risk assessments
- IQ/OQ/PQ documentation
- Periodic review
- Create and manage system changes through formal change control processes.
- Ensure proper system configuration, access control, data integrity, and backup/recovery practices.
- Cross-Functional Collaboration
- Partner with business partners to ensure systems effectively support business needs.
- Act as a subject matter expert (SME) for Quality systems & Processes across the organization.
Requirements
- Bachelor’s degree in Information Systems, Computer Science, Engineering, Life Sciences, or related field.
- 7+ years of experience implementing/supporting GxP-regulated IT systems within pharmaceutical, biotech or equivalent Commercial Operations background.
- Strong knowledge of Quality Systems and QMS business processes.
- Hands-on experience with system validation and compliance in regulated environments.
- In-depth understanding of 21 CFR Part 11, EudraLex Annex 11, and data integrity principles.
- Experience supporting audits and regulatory inspections.
- GxP compliance and regulatory knowledge
- CSA/CSV expertise
- Quality mindset with strong attention to detail
- Excellent communication and stakeholder management skills
- Ability to balance compliance requirements with business efficiency
- Leadership in cross-functional, matrixed environments
Preferred:
- Direct Veeva Vault Quality administration experience.
- Experience supporting automation, engineering, commercial manufacturing, quality operations.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
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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.
