IT Manager, Serialization

Technical Services is recruiting for a IT Manager, Serialization, located in Italy.

The ideal candidate will have experience in correcting and implementing new processes and driving innovation in a large healthcare company.

There will be direct responsibility of managing employees as well as contracted resources via a third-party and through other organizations.

Experience in a matrixed environment and leading support teams is required.

Collaborates with multiple departments on internal strategies and supports organizational objectives and business goals.

Manages initiatives, timelines, approvals, and plans.

Directs activities for strategic initiatives and serves as a primary point of contact for internal and external stakeholders.

Key Responsibilities:


* Acts as a domain expert on Functional Engineering technology management capability and scope definition, solution design, configuration, extension, and enablement through to final deliverables.


* Liaisons cross-functionally to help identify and build Functional Engineering products that comprehensively address specific customer business needs and requirements.


* Lead projects of various sizes with limited supervision through the software development lifecycle utilizing Agile methodologies and tools.


* End-to-End delivery of major Manufacturing application and platform Build and Run Services


* Perform assessment, develop plan, and support models for all Manufacturing systems


* Determine optimization opportunities and execute to result in reduced Total cost of ownership while maintain established Service Levels.

Establish standard processes.


* Manage extended, global, enterprise teams of internal and external professionals.


* Participate in the business planning activities (budgets, projects and resource planning).

Interview, hire and manage outside contractors as required.


* Execute Vendor optimization strategies and optimized support models


* Ensure execution excellence in the delivery of I/T objectives and delivering.

Ensure IT compliance (WICO, HIPAA, GXP, 21 CFR Part 11, WICO, Records Management, SOX, SDLC, CSV) requirements in all activities and solutions.

Qualifications

Education:


* Bachelor's degree in computer science or related field required or minimum 8 years relevant or regulated industry experience is required.

Experience and Skills:

Required:


* Strong knowledge of manufacturing processes and best practices.


* Expertise in the configuration and implementation of solutions that integrate with ISA-95 L1/L2/L3 applications.


* Working knowledge of serialization applications.


* Experience in application development and support.


* Experience in organizational design, deployment and management.


* Experience in large program management and delivery with benefits delivered as committed.


* Expert experience in GxP systems, Computer System Validation and proven track record in the support of FDA r...