Manager, Data Integrity

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.

• 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.

• 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.

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

Wisconsin pay range: $115,000–$130,000 USD.

Candidates must have current, valid authorization to work in the country where this role is located.