Manager, Data Integrity

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.
• Cook up 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.
• 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).

Benefits

Wisconsin pay range: $115,000 USD - $130,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.