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 will be primarily responsible for drafting, editing, and standardizing GMP documentation for deviations, investigations, CAPAs, and change controls. Ensures records are clear, compliant, complete, and inspection-ready, aligning to site procedures, data integrity expectations, and applicable regulations. Partners with SMEs and cross-functional owners to translate technical content into high-quality QMS records with consistent structure and strong rationale.
Responsibilities
- Draft and edit deviations and investigation narratives (event description, timeline, impact, conclusions).
- Convert SME input into clear root cause documentation aligned to evidence.
- Write CAPAs linked to root cause, including action plans and effectiveness checks.
- Draft change controls (rationale, scope, impacted areas/docs, implementation plan).
- Ensure records are complete, consistent, and inspection-ready (traceability, attachments, objective evidence).
- Apply site procedures and data integrity / cGMP expectations in all Manufacturing QMS records.
- Coordinate with cross-functional owners to improve first-pass approvals and ensure thorough investigations.
- Support audits/inspections by quickly clarifying or revising QMS narratives as needed.
Requirements
- BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry
- 3 years working in a GMP setting with a minimum of 2 years of experience authoring change controls and/or investigating deviations.
- Proficient experience working with controlled documentation
- Experience with internal CAPA investigations
- Proficient project management skills
- Ability to collaborate with and coordinate cross-functional teams
- Proficiency with Microsoft Suite applications (Word, Excel)
- High attention to detail
- Ability to multi-task and manage responsibilities within ongoing projects
Preferred
- 5+ year's GMP experience and 3+ cGMP deviation and/or change control 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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Skills Required
- BS or BA in an applicable scientific field such as chemistry, biology, or biochemistry
- At least 3 years of experience working in a GMP setting
- At least 2 years of experience authoring change controls and/or investigating deviations
- Experience working with controlled documentation
- Experience with internal CAPA investigations
- Project management skills
- Ability to collaborate with and coordinate cross-functional teams
- Proficiency with Microsoft Word and Microsoft Excel
- High attention to detail
- Ability to multitask and manage responsibilities within ongoing projects
- At least 5 years of GMP experience and 3 or more years of cGMP deviation and/or change control experience
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.
