Director of Information Technology

Hartmann Young; Massachusetts; On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Healthcare coverage

Retirement benefits

Educational support

Professional development opportunities

Job summary

Hartmann Young is seeking an Associate Director, Information Technology to lead site IT operations in Massachusetts and drive the digital manufacturing transformation. You will own GMP-regulated software lifecycle, lead MES deployments, and partner with manufacturing, quality, and global IT teams to deliver compliant, scalable technology solutions.

The role requires a strong background in regulated systems, MES platforms, and cross-functional leadership, with a focus on security, validation, and

Qualifications

• Bachelor’s degree in a technical discipline or equivalent.
• Minimum 7 years in a regulated GMP environment, ideally biopharma.
• Leadership or people-management experience.
• Strong MES experience with Emerson Syncade, PAS-X or POMS.
• Experience designing electronic batch records and manufacturing recipes.
• Familiarity with GAMP 5, ISA-88 and ISA-95.
• Experience with ERP in GMP environments.
• Cybersecurity and information security awareness.

Responsibilities

• Lead site IT operations and drive the digital transformation agenda.
• Oversee GMP-regulated computer systems lifecycle: selection, validation, deployment, maintenance, and decommissioning.
• Manage the MES platform (design, configuration, integration, troubleshooting) and ensure regulatory compliance.
• Collaborate with manufacturing, quality, engineering and site leadership; manage external vendors and budgets.
• Support regulatory inspections as the technical SME for manufacturing systems.

Skills

Leadership

IT budgeting

Vendor management

GMP systems

MES systems

Cybersecurity

Cross-functional collaboration

Project management

Education

Bachelor's degree in Computer Science or related field

Tools

Emerson Syncade

Körber PAS-X

POMS

Job description

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.

Key Responsibilities

Leadership and Site IT Management

• 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.

GMP Systems and Digital Manufacturing

• 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.

Manufacturing Execution 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.

Experience Required

• 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.