IT Head – cGMP Biopharmaceutical Manufacturing Sites

Job Description: IT Head cGMP Biopharmaceutical Manufacturing Sites

Job Summary:

We are seeking an experienced IT Head to lead and manage the Information Technology department at our cGMP biopharmaceutical manufacturing site. The successful candidate will oversee IT operations, ensuring that digital systems comply with US FDA guidelines and cGMP regulations while driving digital transformation, cybersecurity, and operational efficiency. The IT Head will play a pivotal role in adopting innovative digital solutions, improving productivity, and implementing data analytics and reporting systems to support business growth and regulatory compliance.

Key Responsibilities:

Strategic Leadership:

1. Develop and implement a strategic vision for integrating deep tech solutions (AI, Blockchain, Robotics, Biotechnology, Quantum Computing) in vaccine production and quality operations.
2. Align the technology roadmap with the company's overall manufacturing, quality, and compliance objectives
3. Collaborate with across teams to ensure all processes and technologies are audit-ready at all times.
4. Stay updated on emerging trends and regulations in WHO's cGMP requirements and their implications for the tech environment in vaccine production. Ensure that all technology implementations fully comply with WHO's cGMP and regulatory standards for vaccine production.

Digital Transformation, AI, Automation, and Solution Adoption:

1. Drive the digital transformation of manufacturing facilities by adopting cutting-edge AI technologies, automation, and system enhancements.
2. Lead the application of AI in predictive maintenance, process optimization, and real-time monitoring of vaccine production.
3. Identify, select, and implement digital solutions that improve productivity, operational efficiency, and compliance with regulatory standards.
4. Use AI and machine learning to improve predictive quality control, reducing the time and costs associated with traditional QC methods.
5. Implement Blockchain for secure, immutable record-keeping of quality-related data to facilitate audits and improve traceability.
6. Oversee robotics in production areas to minimize contamination risks, ensure precise control of manufacturing environments, and improving operational efficiency.
7. Oversee the integration of digital tools with manufacturing and quality operations, including Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP), Laboratory Information Management Systems (LIMS), and other relevant software platforms.
8. Ensure that deep tech solutions align with WHO's cGMP guidelines for QA, minimizing risk, ensuring data integrity, and automating regulatory compliance reporting.

Data Analytics & Reporting:

1. Develop and manage data analytics and reporting systems to provide real-time insights into production, quality control, and compliance performance.
2. Implement data-driven decision-making tools that allow cross-functional teams to improve operational efficiency and ensure compliance with cGMP standards.
3. Implement Biotechnology advancements to optimize the production of drug substances for bacterial, viral, polysaccharide-based, and conjugate vaccines.
4. Use AI and machine learning to improve predictive quality control, reducing the time and costs associated with traditional QC methods.
5. Collaborate with Quality Assurance (QA) and manufacturing teams to generate timely, accurate reports for internal decision-making and regulatory submissions.

Compliance & Regulatory Management:

1. Ensure all IT systems comply with FDA 21 CFR Part 11 guidelines.
2. Lead validation and qualification of IT systems, ensuring their intended use in cGMP-regulated environments.
3. Monitor and maintain audit trails to track critical system data for manufacturing and quality processes.
4. Prepare IT systems for audits by internal teams and regulatory bodies, including FDA inspections.

IT Infrastructure, Security & Cybersecurity:

1. Manage IT infrastructure, including networks, servers, databases, and backup systems, ensuring system reliability and availability.
2. Implement and enforce cybersecurity protocols to safeguard sensitive manufacturing and regulatory data, ensuring alignment with industry best practices and regulatory standards.
3. Develop and implement disaster recovery and business continuity plans for critical IT systems.

Productivity & Software Management:

1. Identify and implement software solutions that enhance productivity and streamline processes, ensuring they meet both business and regulatory needs.
2. Manage the full life cycle of software applications, including selection, implementation, validation, and decommissioning.
3. Foster relationships with vendors to ensure third-party software meets cGMP and FDA compliance requirements.

Team Leadership & Development:

1. Lead, mentor, and develop the IT team to provide robust support across the site, ensuring the team can manage both operational IT support and compliance requirements.
2. Collaborate with cross-functional teams (e.g., QA, QC, Manufacturing, Supply Chain) to ensure IT services are aligned with organizational goals.
3. Provide training and education on IT systems and processes to ensure staff understand and adhere to compliance requirements.

Innovation & Continuous Improvement:

1. Lead initiatives for continuous improvement through the adoption of innovative technologies, digital tools, and process optimizations.
2. Stay informed on industry trends, emerging technologies, and changes in FDA/cGMP regulations to keep IT infrastructure and systems in alignment with evolving standards and business needs.

Qualifications:

1. Education: Bachelor's or master's degree in information technology, Computer Science, or a related field. Advanced certifications in IT management or regulatory compliance are a plus.
2. Experience: A minimum of 10+ years of experience in IT management, with a strong background in cGMP-regulated environments, ideally within biopharmaceutical or pharmaceutical manufacturing.

Technical Expertise:

• Proven experience with FDA 21 CFR Part 11 compliance for electronic records and signatures.
• Hands-on experience with MES, ERP, LIMS, and other digital tools relevant to manufacturing.
• Strong knowledge of data analytics, cybersecurity best practices, and software life cycle management.
• Experience with IT infrastructure management, including networking, cloud technologies, and disaster recovery planning.
• Leadership Skills: Demonstrated ability to lead IT teams, drive digital transformation, and foster a culture of innovation and compliance.
• Regulatory Knowledge: In-depth understanding of FDA regulations, cGMP requirements, and data integrity principles.
• Problem-Solving: Ability to troubleshoot complex IT and operational issues while implementing effective solutions aligned with regulatory standards.

Key Competencies:

1. Strong understanding of cGMP and FDA regulatory requirements for IT systems in a biopharmaceutical environment.
2. Expertise in cybersecurity and data protection in regulated environments.
3. Strategic thinker with a focus on digital transformation, process optimization, and data-driven decision-making.
4. Excellent leadership, communication, and collaboration skills.
5. Strong organizational skills and the ability to manage multiple projects while ensuring compliance and operational efficiency.

Key Performance Indicators (KPIs):

• Compliance and Audits:

a. Zero non-compliance incidents during WHO or regulatory body audits.

b. Successful implementation of Blockchain and AI systems for audit trails and reporting.

• Production Efficiency:

a. % increase in manufacturing efficiency post-integration of robotics and automation.

b. Reduction in downtime through predictive AI-driven maintenance.

• Quality Assurance:

a. Reduction in product deviations or recalls due to predictive AI and automated QC.

b. Accuracy and timeliness of reporting QA compliance data using blockchain.

• Cost Savings:

a. Reduction in operational costs due to automation and optimization.

b. % decrease in quality control-related costs through AI-enabled quality prediction systems.

• Innovation:

a. Number of research initiatives and technological advancements implemented.

b. Successful trials of quantum computing models for advanced vaccine simulations.

• Data Integrity and Security:

a. 100% data integrity using blockchain for supply chain management and compliance records.

b. No incidents of data breaches or loss of data across manufacturing and QC operations.