Arrowhead Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company seeking a Director, Data Integrity to lead the design, implementation, and continuous improvement of the company's data integrity program across GxP operations. The successful candidate will provide strategic leadership and serve as a cross-functional leader and subject matter expert, partnering across the organization to embed data integrity principles and compliance into systems, processes, and culture.
Requirements
- Bachelor's degree in science, engineering, information technology, computer science, data management, or a related technical discipline.
- Minimum of ten (10) years of experience in the regulated pharmaceutical, biotechnology, or combination product industry.
- Comprehensive knowledge of GxP regulations, including GMP (FDA, EU, etc.), ICH guidelines, and ISO standards.
- Demonstrated expertise with ALCOA++ 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.
- Proven ability to lead complex, cross-functional projects and build effective partnerships to advance data integrity and compliance objectives.
- Strategic thinker with demonstrated success in driving continuous improvement, innovation, and proactive risk management.
- Excellent communication, interpersonal, and leadership skills, with the ability to work with a diverse range of professionals and influence stakeholders at all levels.
Benefits
- Competitive salaries
- Excellent benefit package
- Wisconsin pay range $180,000—$210,000 USD