IT Audit and Compliance Manager
Job Summary
To enhance the partnership between technology and quality, the full-time remote IT Audit and Compliance Manager will oversee the quality management system for technology, manage quality events and deviations, and drive process improvements in compliance and operational effectiveness.
Key responsibilities
- Own and manage quality events, deviations, and CAPAs, ensuring thorough investigations and effective closure
- Redesign workflows between engineering and quality to improve efficiency and compliance outcomes
- Maintain the IT SOP register, ensuring documents are current and accessible, and lead periodic reviews and audits
Required qualifications
- Bachelor's degree in life sciences, engineering, information systems, computer science, or a related field
- 7+ years of experience in quality, compliance, validation, or regulated IT, including 3 years in a GxP environment
- Hands-on technical experience configuring and administering Veeva Vault
- Practical knowledge of FDA 21 CFR Part 11 and risk-based computer software assurance
- Experience with deviations, CAPAs, change control, and document lifecycle in an electronic quality management system
Complete Job Description
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