Lead the site in compliant implementation of a regulated and segmented LAN (Local Area Network), premise services, enterprise systems, cloud storage and redundant onsite backup capabilities. Lead the automation implementation for the site, integrating the equipment, systems and subsequent data capture in a compliant and strategic methodology. Develop and Oversee network functions across facility. Oversee Automation functions across facilities.
The Sr. Manager of Information Systems and Automation is accountable for project completions and achievement of information system and automation goals. They will set ambitious and achievable targets to drive for results based on organizational objectives. Interface with peers and colleagues internal and external to identify and implement best practices. Present plan documents and strategies to Senior Management and regulatory agencies when required. Address and/or escalate site IT, data compliance problems and issues to senior management. Communicate IT and Automation requirements, timelines, and resource needs to senior management. Ensure compliance with appropriate internal and regulatory policies and procedures. This includes appropriate documentation, specifications, and all regulatory requirements. Ensure that all software / computer applications and systems are compliant and meet or exceed industry standards.
• The Sr. Manager of IT and Automation is the leading source of technical IT and Automation related expertise and is responsible for providing the strategic leadership and management for the IT team and overall sight(s).
• Provide leadership to the IT/Automation team to ensure that teamwork, high morale and innovation are fundamental components of a world-class team.
• Serve as the company IT and Automation expert, providing solid, well-informed, actionable support to PD, Validation, Operations and other functions as requested.
• Develop and execute the implementation strategy commensurate with the overall plan for the company. Ensure alignment with customer needs and linkage with the overall Regulatory, Quality and business strategies.
• Bachelor`s Degree in a Life science, Engineering or Quality Management or related science discipline
• 5+ years direct job-related experience in GMP facility manufacturing products regulated by CBER or CDER or with a minimum of 2 years’ experience in regulated information systems and management.
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