Manager,DataIntegrity

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, Demonstrated ability to coordinate or guide team-level work, Comprehensive knowledge of GxP regulations, Knowledge of GMP (FDA, EU, etc.), Knowledge of ICH guidelines, Knowledge of ISO standards, Demonstrated expertise with data integrity principles, Demonstrated expertise with data lifecycle management, Demonstrated expertise with data governance frameworks, Proven experience applying 21 CFR Part 11, Proven experience applying Annex 11, Proven experience applying other relevant regulations, Understanding of information technology, Understanding of data management systems, Understanding of system validation, Understanding of security, Understanding of enterprise data governance, Demonstrated ability to coordinate cross-functional tasks, Demonstrated ability to build effective peer relationships, Demonstrated ability to advance data integrity objectives through influence, Ability to manage competing priorities, Ability to escalate risks appropriately, Ability to deliver on commitments, Written communication, Verbal communication, Previous experience with EDMS / EQMS