Director Of Information Technology at Cellectis (Raleigh, NC)

We are seeking a highly motivated leader to join our Information Technology group as a Director of IT for our US sites to support our supply chain, manufacturing, finance, innovation and research and development business groups. Based out of our Manhattan office this critical leadership role is responsible to work with our Paris based IT team along with building a US team to identify, design and implement system solutions to enable new business capability requirements at both the Manhattan office and the US manufacturing site.

            Responsibilities:

• Functional ownership and responsibility of various US based Technical Operations and Enterprise applications and solutions to deliver Cellectis UCART therapies to patients worldwide.
• Be a trusted partner within IT and with US business stakeholders while identifying the technology capabilities to meet their strategic business roadmap.
• Collaborate with US based supply chain, manufacturing, procurement, finance, HR, Quality, Innovation, R&D and other business functions to understand their roadmap and identify the best fit technology solutions to enable business capabilities.
• Responsible for the identification, prioritization, implementation and integration of an Enterprise Resource Planning System, Quality Management System, LIMS and MODA for Cellectis and for the integration of these systems to support day to day operations.
• Bring best practices to deliver solutions for the business problems through experience driven vision, planning to support the business partners.
• Leverage standard out of the box system functionalities to the greatest extent possible while delivering solutions that enable our business partners to be effective, efficient and agile.
• Lead IT Governance and Change control amongst US IT and business teams to prioritize and implement improvements to critical systems maintaining GxP validation, HIPPA and SOX Compliance.
• Work closely with Quality, Computer System Validation, Regulatory and internal audit teams to ensure the compliant and validated state for GMP system operations and financial reporting.
• Collaborate closely with IT delivery and release management teams and also other groups like infrastructure and PMO on large project implementations and also with day to day sustaining projects and enhancements.
• Assist in evaluating vendor solutions, develop alternatives and recommend technical solutions in meeting the evolving needs of the business.
• Partner with software vendors, implementation partners, integrators and solution providers for the end to end business solutions delivery.
• Lead and manage a team of highly skilled internal and vendor business analysts, functional experts and solution architects to identify and deliver business capabilities through technology solutions.
• Understand short term and long-term data analytics and reporting requirements and implement technology solutions for data warehouse and reporting.

Knowledge & Experience:

• Masters or Bachelors degree in Engineering, Computer/Information Sciences, Business Administration or any other equivalent field.
• 15+ years of extensive experience in leading implementation, delivery and execution of key TechOps and enterprise systems including Manufacturing Execution Systems, Quality systems, Product Life Cycle systems and other cloud-based applications that are capable of integration.
• 5+ years of hands on experience in ERP/MES implementation and configurations preferably in a Biotech/Pharmaceutical manufacturing environment.
• Experience in non-ERP applications such as LIMS, EQMS, MODA, MES will be a big plus.
• 5+ years of strong people management, leadership and team development skills.
• Strong experience in owning end to end system footprint consisting of ERP systems such as SAP, Oracle EBS, Netsuite and various other cloud or externally hosted/managed systems.
• Possess can do attitude and business acumen to solve business problems and take initiative to find opportunities for continuous improvement. Be a quick learner and ready to change hats quickly as needed.
• Experience in an FDA/EMEA -regulated, GxP-related environment in a Biotech or Pharmaceutical company and also experience with SOX internal audit as well as HIPAA controls is a plus.
• Experienced in managing on-Premise, Web/Mobile and cloud SaaS based applications.
• Solid understanding of various project management methodologies to own and successfully implement large projects
• Self-motivated with high degree of initiative and excellent follow-up skills, along with strong analytical and problem-solving skills.
• Excellent interpersonal, verbal and written communication and presentation skills and ability to interact and interface with all levels of business including senior leadership team
• Experience in developing design functional specifications, test scripts, and training documents.
• Comfortable in a fast-paced small company environment with minimal direction, but also able to follow the processes and policies of large regulated corporations.

Candidate Profile:

• Strong experience in owning end to end system footprint consisting of ERP systems such as SAP, Oracle EBS, NetSuite and various other cloud or externally hosted/managed systems.
• Possess can do attitude and business acumen to solve business problems and take initiative to find opportunities for continuous improvement. Be a quick learner and ready to change hats quickly as needed.
• Experience in an FDA-regulated, GxP-related environment in a Biotech or Pharmaceutical company and experience with SOX internal audit as well as HIPAA controls is a plus.
• Experienced in managing on-Premise, Web/Mobile and cloud SaaS based applications.
• Solid understanding various project management methodologies to own and successfully implement large projects
• Self-motivated with high degree of initiative and excellent follow-up skills, along with strong analytical and problem-solving skills.
• Excellent interpersonal, verbal and written communication and presentation skills and ability to interact and interface with all levels of business including senior leadership team
• Experience in developing design functional specifications, test scripts, and training documents.
• Comfortable in a fast-paced small company environment with minimal direction, but also able to follow the processes and policies of large regulated corporations.
• Strong collaborative skills and ability to work well in a cross-functional, matrixed environment.

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