Location: Miami, Florida, United States Job Hours: Regular Compensation: $70,000 to $75,000 per annum
A premier Manged solutions company focused on Accounting, Finance and Information Technology. If you are seeking a new opportunity, seeking empowered professionals, or project based solution services.
This position is responsible for leading in the design, review, documentation, assessment, and testing of the internal controls and validation deliverables within Information Management to support compliance and regulatory initiatives. Supports Management with internal and external audits. Track laws and regulations that might affect the organization's policies. Partner with the Business to ensure ongoing compliance. Providing strong central oversight to guarantee consistency and quality in compliance work within IM. Coordinating the annual audit and testing processes with Internal and External auditors. Develop Internal testing strategy and processes to ensure all policies and procedures adhere to the regulations. Prepare compliance reports to present to upper management. This position provides leadership to the group that allows for flexibility within the team, cultivates team members and provides motivation to achieve goals and foster career development. Remain knowledgeable of information management, regulatory, Quality Assurance and company business operations. Recommend the implementation of technology or processes to support the company's objectives. Oversees the documentation of systems to ensure they meet the standards and policies. Provides regular status reports to supervisor. Special projects as assigned.
Education / Skills Required:
Bachelor degree in Information Science, Computer Science, Software Engineering or other related field or equivalent combination of training and experience. Five or more years of experience with information services. Five or more years of experience in Computer System Validation in an FDA regulated environment. Good knowledge of project leadership or management. Excellent written and verbal communication skills with specific departmental knowledge. Good judgment and strong attention to detail required; effective organizational capabilities.
CRITICAL TO HIRE:
1. High level proficiency in Computer Systems Validation.
2. High level proficiency in Regulatory Compliance. (FDA, 404c)