Associate Director, Information Technology
About The Position
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.
Requirements
- 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
- Prior MES 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.
Responsibilities
- Lead the site ITS team and represent the ITS on the site leadership team.
- Responsible for developing and managing US site IT budget.
- Ensure the achievement of site digital transformation and global IT goals such as system implementation, infrastructure, desktop support and cyber security.
- 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 to RoslinCT.
- 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.
- Be an MES subject matter expert to assist in regulatory audits and investigations.
Benefits
- flexible and empowering work environment
- attractive benefits package
- emphasis on work-life balance
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What This Job Offers
Job Type
Full-time
Career Level
Manager
