Manager, Data Integrity
$115,000–$130,000 year
On-site · Verona, Wisconsin, United States
Job Summary
Hands-on manager leading data integrity initiatives across GxP operations. Executes and supports the implementation of data integrity policies, procedures, and program elements in alignment with global regulatory requirements; identifies gaps and drives remediation. Coordinates cross-functional data integrity activities, serves as a working-level point of contact to maintain program momentum, conducts data integrity impact assessments and risk evaluations, and supports remediation plans. Evaluates data management practices, documents findings for risk-based validation and assurance activities (CSV/CSA), participates in data integrity audits, and contributes to CAPA and process-improvement initiatives. Manages and mentors direct reports, supports training on ALCOA++ principles and regulatory requirements, assists in regulatory inspections and partner audits, and supports ongoing data governance initiatives. Requires a Bachelor’s degree and at least five years in regulated pharma/biotech, with strong knowledge of 21 CFR Part 11, Annex 11, and related guidance, and experience with EDMS/EQMS. Occasional travel may be required.
Required Qualifications
- Bachelor's degree in science, engineering, information technology, computer science, data management, or related technical discipline
- Minimum of five (5) years of experience in the regulated pharmaceutical, biotechnology, or combination product industry
- Comprehensive knowledge of GxP regulations (GMP, FDA, EU, ICH, ISO)
- 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 (validation, security, enterprise data governance)
- Ability to coordinate cross-functional tasks and influence without formal authority
- Detail-oriented, solutions-focused, with ability to manage competing priorities and deliver commitments
- Strong written and verbal communication skills; ability to translate compliance requirements for cross-functional teams
- Experience with electronic document/quality management systems (EDMS/EQMS)
- Ability for occasional business travel
- Preferred: Advanced degree; Certification or formal training in quality management, data integrity, data governance, or regulatory compliance
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