Manager, Data Integrity
Arrowhead Pharmaceuticals
June 24, 2026
Remote friendly (Madison, WI)
United States
$115,000 - $130,000 USD yearly
IT
The Position
- Serve as a hands-on team leader and subject matter expert supporting data integrity and quality management programs across GxP operations. Execute assessments, drive remediation, and maintain compliance with data integrity frameworks/standards (e.g., 21 CFR Part 11, Annex 11, PIC/S), and contribute to QMS execution and compliant data management practices.
Responsibilities
- Implement data integrity policies, procedures, and program elements; identify gaps and drive remediation.
- Coordinate cross-functional data integrity activities; act as working-level point of contact.
- Conduct data integrity impact assessments, risk evaluations, remediation plans; track and close commitments.
- Evaluate data management, documentation, and record control practices; flag non-conformances and support corrective action.
- Assess computerized systems/software/equipment for compliance with 21 CFR Part 11, Annex 11; support CSV/CSA.
- Support data integrity audits/assessments; lead risk identification, gap analysis, mitigation.
- Author/execute CAPAs and process improvements for data integrity controls.
- Manage and mentor direct reports; build team capability.
- Develop/deliver data integrity training; serve as go-to resource for ALCOA++ and compliant practices.
- Support regulatory inspections and partner audits; prepare documentation and respond to inquiries.
- Support data governance initiatives and compliant data management.
Requirements
- Bachelor’s degree in science/engineering/IT/computer science/data management or related field.
- 5+ years in regulated pharma/biotech/combination products, with ability to coordinate/guide team work.
- Comprehensive GxP knowledge (GMP, ICH, ISO).
- Expertise in data integrity principles, data lifecycle management, and data governance.
- Proven experience with 21 CFR Part 11, Annex 11, and related guidance.
- Strong understanding of IT/data systems, validation, security, and enterprise governance.
- Ability to influence cross-functionally without formal authority; manage priorities and risks.
- Strong written/verbal communication.
- Experience with EDMS/EQMS.
- Occasional business travel.
Preferred
- Advanced degree.
- Certification/training in quality management, data integrity, data governance, or regulatory compliance (e.g., ASQ, ISPE, PDA).
Benefits / Application
- Wisconsin pay range: $115,000–$130,000 USD.
- Candidates must have current, valid authorization to work in the country where this role is located.
- Serve as a hands-on team leader and subject matter expert supporting data integrity and quality management programs across GxP operations. Execute assessments, drive remediation, and maintain compliance with data integrity frameworks/standards (e.g., 21 CFR Part 11, Annex 11, PIC/S), and contribute to QMS execution and compliant data management practices.
Responsibilities
- Implement data integrity policies, procedures, and program elements; identify gaps and drive remediation.
- Coordinate cross-functional data integrity activities; act as working-level point of contact.
- Conduct data integrity impact assessments, risk evaluations, remediation plans; track and close commitments.
- Evaluate data management, documentation, and record control practices; flag non-conformances and support corrective action.
- Assess computerized systems/software/equipment for compliance with 21 CFR Part 11, Annex 11; support CSV/CSA.
- Support data integrity audits/assessments; lead risk identification, gap analysis, mitigation.
- Author/execute CAPAs and process improvements for data integrity controls.
- Manage and mentor direct reports; build team capability.
- Develop/deliver data integrity training; serve as go-to resource for ALCOA++ and compliant practices.
- Support regulatory inspections and partner audits; prepare documentation and respond to inquiries.
- Support data governance initiatives and compliant data management.
Requirements
- Bachelor’s degree in science/engineering/IT/computer science/data management or related field.
- 5+ years in regulated pharma/biotech/combination products, with ability to coordinate/guide team work.
- Comprehensive GxP knowledge (GMP, ICH, ISO).
- Expertise in data integrity principles, data lifecycle management, and data governance.
- Proven experience with 21 CFR Part 11, Annex 11, and related guidance.
- Strong understanding of IT/data systems, validation, security, and enterprise governance.
- Ability to influence cross-functionally without formal authority; manage priorities and risks.
- Strong written/verbal communication.
- Experience with EDMS/EQMS.
- Occasional business travel.
Preferred
- Advanced degree.
- Certification/training in quality management, data integrity, data governance, or regulatory compliance (e.g., ASQ, ISPE, PDA).
Benefits / Application
- Wisconsin pay range: $115,000–$130,000 USD.
- Candidates must have current, valid authorization to work in the country where this role is located.