Job Description

IT Infrastructure Management:

• Oversee the design, implementation, and maintenance of IT infrastructure, including networks, servers, databases, and enterprise systems, ensuring high availability and performance.
• Manage and optimize IT systems to support API production, inventory management, quality control, and laboratory information systems (LIMS).

Regulatory Compliance & Validation:

• Ensure all IT systems and processes comply with relevant regulatory requirements (e.g., 21 CFR Part 11, GxP).
• Manage and oversee the validation of computer systems used in API manufacturing and quality processes.
• Develop and implement IT policies and procedures to ensure data integrity, security, and auditability.

Project Management:

• Lead and manage IT projects from initiation to completion, ensuring timely delivery, within budget, and meeting project objectives.
• Collaborate with cross-functional teams to identify technology solutions that enhance operational efficiency and support business goals.

Team Leadership & Development:

• Supervise, mentor, and develop a team of IT professionals, fostering a collaborative and high-performing environment.
• Provide technical guidance and support to the IT team and other departments.

Security & Data Integrity:

• Implement and maintain robust cybersecurity measures to protect sensitive data and intellectual property.
• Develop and manage disaster recovery plans and business continuity strategies for IT systems.

Vendor Management:

• Manage relationships with IT vendors and service providers, ensuring service level agreements (SLAs) are met.
• Evaluate and select new technologies and solutions that align with the organization's strategic objectives.

Skills Required