Arrowhead Pharmaceuticals

Manager, Data Integrity

Verona, Wisconsin, United States

Sponsorship not specified$115k-$130kDetected 18 days ago

ComplianceProcess ImprovementGMPFDA RegulatoryResearchAnimal StudiesCommunicationGxP

About the role

Serve as a hands-on team leader and subject matter expert supporting the company's data integrity and quality management programs across GxP operations.

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.
flag non-conformances and support corrective action.
document findings and support risk-based computer system validation and assurance activities (CSV/CSA).
Participate in and support data integrity audits and assessments
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

Bachelor's degree in science, engineering, information technology, computer science, data management, or a related technical discipline.
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.
Previous experience with the use of electronic document / quality management systems (EDMS / EQMS).
Candidates must have current, valid authorization to work in the country where this role is located.

Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

Advanced degree preferred.
Certification or formal training in quality management, data integrity, data governance, or regulatory compliance (e.g., ASQ, ISPE, PDA, or equivalent).

This listing is sourced directly from Arrowhead Pharmaceuticals's careers page and normalized into a canonical job model.