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
Serve as a hands-on team leader and subject matter expert supporting the company’s data integrity and quality management programs across GxP operations. This role is responsible for executing assessments, driving remediation, and maintaining compliance with applicable data integrity frameworks and standards (e.g., 21 CFR Part 11, Annex 11, , PIC/S), while contributing to QMS program execution and compliant data management practices.. The role is expected to interact with multiple internal departments in support of data integrity management initiatives.
Responsibilities
- Execute and support the implementation of data integrity policies, procedures, and program elements in alignment with global data integrity regulatory requirements; identify gaps and drive hands-on remediation.
- Coordinate cross-functional data integrity activities, serving as a working-level point of contact to maintain program momentum and support peer teams in adopting compliant data management practices.
- Conduct data integrity impact assessments, risk evaluations, and remediation plans; track progress and ensure timely closure of commitments.
- Evaluate data management, documentation, and record control practices across systems and formats; flag non-conformances and support corrective action.
- Assess computerized systems, software, and equipment for compliance with 21 CFR Part 11, Annex 11, and related guidance; document findings and support risk-based computer system validation and assurance activities (CSV/CSA).
- Participate in and support data integrity audits and assessments; contribute to risk identification, gap analysis, and mitigation execution.
- Author and execute CAPAs and process improvement initiatives to strengthen data integrity controls.
- Manage and mentor direct reports to support professional development and build data integrity team capability.
- Support in the development and delivery of data integrity training materials; serve as a go-to resource for team members on ALCOA++ principles, regulatory requirements, and compliant data practices.
- Support regulatory inspections and partner audits as a subject matter contributor; prepare documentation and respond to data integrity inquiries.
- Support ongoing data governance initiatives and compliant data management practices aligned with regulatory expectations.
- Perform additional duties as assigned to support objectives.
Requirements:
- Bachelor's degree in science, engineering, information technology, computer science, data management, or a related technical discipline.
- Minimum of five (5) years of experience in the regulated pharmaceutical, biotechnology, or combination product industry, including demonstrated ability to coordinate or guide team-level work with increasing scope of responsibility.
- Comprehensive knowledge of GxP regulations, including GMP (FDA, EU, etc.), ICH guidelines, and ISO standards.
- Demonstrated expertise with data integrity principles, data lifecycle management, and data governance frameworks.
- Proven experience applying 21 CFR Part 11, Annex 11, and other relevant regulations and guidance governing data integrity and information security.
- Strong understanding of information technology and data management systems, including system validation, security, and enterprise data governance.
- Demonstrated ability to coordinate cross-functional tasks, build effective peer relationships, and advance data integrity objectives through influence without formal authority.
- Detail-oriented and solutions-focused, with demonstrated ability to manage competing priorities, escalate risks appropriately, and deliver on commitments.
- Strong written and verbal communication skills; able to translate technical compliance requirements into clear, actionable guidance for cross-functional teams.
- Previous experience with the use of electronic document / quality management systems (EDMS / EQMS).
- Ability for occasional business travel.
Preferred:
- Advanced degree preferred.
- Certification or formal training in quality management, data integrity, data governance, or regulatory compliance (e.g., ASQ, ISPE, PDA, or equivalent).
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
- Bachelor's degree in science, engineering, information technology, or related field
- Minimum of five years of experience in the regulated pharmaceutical or biotechnology industry
- Comprehensive knowledge of GxP regulations, including GMP and ICH guidelines
- Proven expertise with data integrity principles and frameworks
- Strong understanding of IT and data management systems
- Ability to coordinate cross-functional tasks
- Strong written and verbal communication skills
- Previous experience with electronic document / quality management systems
- Advanced degree preferred
- Certification in quality management or data integrity preferred
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.
