The Associate Director of Information Technology is a leadership position that will plan, direct, and be responsible for the Software system lifecycle:

• Selection
• Design and configuration,
• Validation
• Deployment,
• Upgrade and maintenance,
• Continuous improvement and Decommissioning

The major software system in deployment is the Material Management and Manufacturing Execution System (MES), currently POMS. Responsibility will also include support for systems such as the QMS, label printing, validation and equipment software.

The role will manage the local IT support team. The individual will work in close collaboration with the site business teams and the Global IT Infrastructure, support and security team.

How You Will Make an Impact:

Leadership and management:

• Lead the site ITS team and represent the ITS on the site leadership team.
• Responsible for developing and managing USsite IT budget.
• Ensure the achievement of site digital transformation and global IT goal such as system implementation,infrastructure, desktop support and cyber security.

Software development and management

• Manage relationships with GMP technology vendors, solution providers, consultants, and outsourcing firms. Manage consulting engagements to achieve both stakeholder satisfaction and costs.
• Negotiation and relationship management for GMP technology partners, including initial and annual due diligence, renewals and pricing, technology comparisons, and evaluations.
• Support integration, validation, administration, and maintenance activities of the site's GMP computer systems.
• Be a site leader in cGMP manufacturing software technology configuration and deployment,develop technical expertise, conduct on-site training, etc.
• Stay informed about strategic and emerging technologies. Adopting and implementing new technologies/services where it can deliver meaningful value toRoslinCT.

Manufacturing Execution System

• Function as a site technical expert for all questions and issues related to the MES system supporting the manufacturing of cell therapy products.
• Perform and direct the design, configuration, and recipe authoring activities of the site's MES application.
• Directly support operations with troubleshooting and issue resolution with respect to the MES system.
• Lead MES projects to meet deliverables, technical, budget, and schedule goals including managing the work of internal and external resources and following up to ensure the desired result has been achieved.
• Support the life-cycle maintenance of GMP manufacturing systems including developing programs for software backups, updates, diagnostics, documentation, and obsolescence planning.
• Capable of being an MES subject matter expert to assist in regulatory audits and investigations.

Qualifications;

• BS in Computer Science,Engineering, Engineering Technology, or other Technical Degree with a minimum of 7 years' experience working in a regulated GMP environment, preferably in biopharmaceutical manufacturing.
• Evidence of teamwork, leadership and initiative taking including management experience
• PriorMES experience with Emerson Syncade, Werum PAS-X, or POMS required.
• Understanding of Warehouse and Inventory management specifically and implementation of ERP systems in a GMP facility.
• Demonstrated proficiency with experience designing and implementing EBR recipes using GAMP5, S88 and S95 standards.
• Familiarity with cybersecurity compliance and information security in a compartmentalized scientific/technical R+D and business computing environment
• Proficient with MS Word, Excel, PowerPoint, and other MS Office suite applications.

Final compensation will be based on a variety of factors, including education, experience, technical expertise, specialized skill sets, market demand, internal equity, and business needs.

At RoslinCT, we offer more than just competitive pay. Our comprehensive Total Rewards package is designed to support your health, financial well-being, and professional development throughout your career. Benefits include medical, dental, and vision insurance, educational assistance, a 401(k) program, and a variety of additional resources to help you thrive both personally and professionally.

Department Information Technology Locations Hopkinton Yearly salary $150,000 - $180,000 Employment type Full-time