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Job Description: IT Manager, Pharmaceutical Manufacturing Company Job Summary: The IT Manager is a critical role responsible for the overall planning, organization, and execution of all IT functions within our pharmaceutical manufacturing environment. This position ensures the reliability, security, and efficiency of our IT infrastructure, applications, and systems, while adhering to regulatory requirements (e.g., GMP, GAMP 5, 21 CFR Part 11). The IT Manager will lead a team of IT professionals and collaborate with cross-functional departments to support the company's strategic objectives. Responsibilities: Strategic Planning & Leadership: Develop and implement IT strategies aligned with the company's business goals and regulatory requirements. Lead and manage the IT department, including recruitment, training, performance management, and team development. Provide strategic guidance and recommendations on technology solutions to improve operational efficiency and compliance. Manage IT budgets and resources effectively. Infrastructure Management: Oversee the design, implementation, and maintenance of the company's IT infrastructure, including servers, networks, databases, and storage systems. Ensure high availability, reliability, and security of IT systems. Manage and support manufacturing systems (e.g., MES, ERP, LIMS) in a GMP environment. Plan and execute system upgrades and migrations. Manage and maintain all computer systems used in the manufacturing and laboratory environments. Regulatory Compliance & Security: Ensure compliance with relevant regulations and standards, including GMP, GAMP 5, 21 CFR Part 11, and data privacy regulations. Develop and implement IT policies, procedures, and SOPs to maintain compliance and security. Conduct regular IT audits and risk assessments. Manage IT security measures, including firewalls, intrusion detection systems, and data encryption. Manage the validation of computerized systems. Application Management & Support: Manage and support critical business applications, including ERP, MES, LIMS, and other manufacturing-related systems. Collaborate with business users to identify and resolve application issues. Manage software licensing and vendor relationships. Oversee the development and implementation of custom applications as needed. Disaster Recovery & Business Continuity: Develop and implement disaster recovery and business continuity plans. Conduct regular backups and recovery tests. Ensure data integrity and availability in the event of a disaster. Vendor Management: Manage relationships with external IT vendors and service providers. Negotiate contracts and ensure service level agreements are met. Evaluate and select new IT vendors and technologies. Project Management: Manage IT projects from initiation to completion, ensuring projects are delivered on time and within budget. Coordinate with internal and external stakeholders to ensure project success. Document project plans, progress, and outcomes. Help Desk and End User Support: Oversee the help desk function, ensuring timely and effective support to end users. Maintain documentation of IT issues and resolutions. Ensure the proper function of all computers, printers, and other end user devices. Qualifications: Bachelor's degree in Computer Science, Information Technology, or a related field. Minimum 5 years of experience in IT management, preferably in a pharmaceutical manufacturing environment. Strong knowledge of GMP, GAMP 5, 21 CFR Part 11, and other relevant regulations. Experience managing and supporting manufacturing systems (e.g., MES, ERP, LIMS). Proven experience in IT infrastructure management, network administration, and cybersecurity. Excellent leadership, communication, and interpersonal skills. Strong project management skills. Experience with computer system validation. Experience with Cloud computing environments is a plus. Experience with data integrity best practices. Preferred Qualifications: Relevant certifications (e.g., PMP, ITIL, CISSP). Master's degree in a related field. Skills: IT infrastructure management Network administration Cybersecurity GMP/GAMP 5/21 CFR Part 11 compliance Manufacturing systems (MES, ERP, LIMS) Project management Vendor management Budget management Leadership and team management Problem-solving and analytical skills Excellent written and verbal communication. To Apply: Please submit your resume and cover letter to hr@gsbpl.com
