Principal Enterprise Architect – GMP Systems

Principal Enterprise Architect – GMP Systems

Requirements

• Bachelor’s degree in computer science or related technical field
• A minimum of 10+ years within IT in a cGMP environment in the biotech/biopharma industry with a minimum of 5 years leadership experience. Cell/Gene Therapy and CDMO experience a plus
• Experience Implementing Manufacturing, Quality, and Supply Chain applications, including ERP, MES, LIMS, QMS, etc.
• Must be able to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment while providing clear direction to team member
• History of developing and building cohesive, high-performing teams with a strong sense of mission, providing training and mentoring to build sufficient management depth throughout the organization and ensure strong succession planning
• Strong analytical, problem-solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability
• Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organization
• Excellent organizational and communication skills
• Self-motivated and passionate about advancing the field of cell therapy
• Self-awareness, integrity, authenticity, and a growth mindset

Responsibilities

• Oversee the global IT function for GMP systems, ensuring consistency, scalability, and compliance across all regions
• Develop and maintain a comprehensive technical blueprint for GMP systems, aligning technology services with business objectives and regulatory requirements
• Provide architectural leadership in resolving inter-program and inter-project issues related to GMP systems
• Oversee the hiring, development, and performance management of staff within IT GMP Systems
• Partner with the IDMO Business to develop and execute against an IT roadmap and deliver on the IT infrastructure needed to manufacture autologous and allogeneic cell therapy products
• Drive the selection, implementation, and support of various business applications, including ERP, MES, LIMS, QMS, etc.
• Work closely with Validation and Quality in deploying and supporting IT GMP Systems
• Manage and coordinate employees, contractors, and agencies, contractors involved in development projects to ensure alignment with project goals, timelines, budgets, and quality standards
• Establish KPIs, monitor progress, and keep critical stakeholders informed of progress for IT projects and strategic initiatives
• Establish key stakeholder relationships with internal and external stakeholders
• Work closely with other functional areas to develop and execute against the strategic plan for all Cellares sites
• Develop, manage, and track a budget for the department
• Negotiates and contracts with consultants, technical personnel, and vendors for services and products needed to support the IDMO IT infrastructure
• Serve as a subject matter expert (SME) during audits or inspections by regulatory authorities.

Preferred Qualifications

No preferred qualifications provided.