Director of Information Technology

Position:
Associate Director, Information Technology

Cell & Gene Therapy Manufacturing | United States

A specialist cell and gene therapy contract development and manufacturing organisation is seeking a Director of Information Technology to lead site-based IT operations and support its continued digital transformation.

This is a senior leadership position with responsibility for the complete lifecycle of regulated software systems, including selection, configuration, validation, deployment, maintenance, continuous improvement and eventual decommissioning.

The successful candidate will lead the local IT support team and work closely with site leadership, manufacturing, quality and global IT functions. A central focus will be the site’s Manufacturing Execution System (MES), alongside other regulated platforms supporting quality management, labelling, equipment and manufacturing operations.

• Lead the site IT team and represent IT within the site leadership group.
• Develop and manage the site IT budget.
• Deliver site and global technology objectives across system implementation, infrastructure, desktop support and cybersecurity.
• Build strong relationships with manufacturing, quality and other operational stakeholders.
• Manage external technology vendors, consultants and solution providers.
• Oversee commercial negotiations, vendor due diligence, renewals, pricing and technology evaluations.

• Lead the integration, validation, administration and maintenance of GMP-regulated computer systems.
• Provide technical leadership for the configuration and deployment of manufacturing software.
• Support the selection and implementation of new technologies that deliver meaningful operational or compliance improvements.
• Ensure regulated systems remain secure, reliable, validated and fit for purpose throughout their lifecycle.
• Support regulatory inspections and investigations as the technical subject-matter expert for manufacturing systems.

• Serve as the site technical authority for the MES platform supporting cell therapy manufacturing.
• Lead system design, configuration, electronic batch record and recipe-authoring activities.
• Partner directly with manufacturing teams to troubleshoot system issues and maintain operational continuity.
• Lead MES projects against agreed technical, budgetary and scheduling objectives.
• Coordinate internal teams, consultants and external technology partners.
• Establish appropriate controls for system backups, updates, diagnostics, documentation and obsolescence planning.

• Bachelor’s degree in Computer Science, Engineering, Engineering Technology or another relevant technical discipline.
• At least seven years of experience within a regulated GMP environment, ideally supporting biopharmaceutical manufacturing.
• Previous leadership or people-management experience.
• Strong practical experience with an MES platform such as Emerson Syncade, Körber PAS-X or POMS.
• Experience designing and implementing electronic batch records and manufacturing recipes.
• Working knowledge of GAMP 5, ISA-88 and ISA-95 principles.
• Understanding of warehouse and inventory-management processes, including ERP implementation within a GMP facility.
• Familiarity with computer system validation, cybersecurity compliance and information security.
• The ability to work effectively across manufacturing, quality, engineering, IT and senior site leadership teams.

The organisation offers a competitive compensation and benefits package, including healthcare coverage, retirement benefits, educational support and opportunities for continued professional development.

Further information about the organisation will be shared with suitable candidates during the recruitment process.