Dear Partners,
I have the following immediate need:
Location: Holly Springs, NC
Duration: 12 +Months
Lead Implementation of SAP mini masters based on global master data and organizational information. Would not include local compensation, benefits, payroll interfaces, and plan administration
¨      Responsible for engaging IT, business, technical, and external consulting partners in project concept development, justification/value assessment, scope and solution definition, implementation planning, system validation design, resource and budget planning and management.
¨      Responsible in conjunction with business-side project owners and their IT advocates for pursuit of approval through governance processes, partnering with all levels of management in IT and the business in setting strategic direction for project approval and execution.
¨      Define, manage, and lead teams composed of IT and business professionals in computer system implementations.
¨      Leadership role in analysis of current business processes, identification of gaps and inefficiencies, and ability to develop and apply technological solutions.
¨      Coordinate the introduction and adoption of reengineered processes and new IT infrastructure to the business environment as needed.
¨      Responsible for planning of required resources to implement cost effective IT solutions.
¨      Leadership role in evaluating and selecting third-party software products, specifying required customization and systems integration tasks, and overseeing the technical performance of contractors.
¨      Coordinate required system validation activities to support GxP, 21CFR Part 11, and ISO 9001 compliant systems and business processes relating to applications implementation.  Author or coordinate authoring of necessary documents to meet system validation requirements under the Novartis Computer System Validation Methodology. 
¨      Creation of project documentation including (but not limited to): project plans, user and technical requirements, financial summaries, executive overviews, and testing documents.
¨      Actively participate in the testing and acceptance of application software or infrastructure solutions.
¨      Partner with business and consulting partners in driving development and delivery of end-user documentation and training materials related to project requirements. 
¨      Manage complex project and organizational issues and risks from identification, through assessment of mitigation approaches, through successful conclusion.
¨      Coordinate with production support teams to ensure availability of support organization and to transfer support activities from project team at end of projects.
¨      Project management skills.  Adept at coordinating competing priorities and projects.  Ability to manage multiple projects simultaneously.  Broad experience in IT project management and ability to lead all phases of complex IT projects. This should include: understanding the business; defining project objectives; determining business & system requirements; project planning; selecting a team and assigning project responsibilities; negotiating project deliverables; evaluating and selecting solutions; designing and testing; implementing and maintaining appropriate solution.
¨      Outstanding communication skills, both verbal and written.  Ability to engage, interact, and negotiate effectively with stakeholders of all levels, including senior executives.
¨      Understanding of client/server and web-based systems architecture concepts and network communications.
¨      Strong interpersonal, technical leadership and mentoring skills.  Thorough understanding of risk management and mitigation approaches for complex organization and project issues.
¨      Results-oriented, pragmatic approach to problem solving.  Ability to act as advocate for consensus on complex issues.
¨      Technical familiarity with Windows, Oracle, SQL, and Citrix technologies.
¨      Thorough understanding of FDA Regulatory requirements regarding software validation, change control, and 21CFR Part11 as pertains to the Pharmaceutical Industry
¨      Significant experience in leading large-scale business application deployment (e.g., SAP, Siebel, Cognos) and/or enterprise solutions for manufacturing for clinical diagnostic equipment or vaccine research & development.
¨      Thorough understanding of how to work effectively within regulated pharmaceutical environment.  Familiarity with U.S. FDA GxP, and U.S. FDA 21CFR Part 11, ISO 9001 systems validation.  Experience in planning and execution of U.S. FDA-related Computer Systems Validation methodologies and project management implications.
¨      Experience developing, implementing and supporting information systems in the pharmaceutical or biotechnology industries.
¨      Thorough, applied understanding of SDLC and Project Methodologies.
¨      Experience planning and implementing systems integration and development projects
¨      Familiarity with network servers, PC clients, and telecommunications technologies

Please send relevant resume with rate confirmation and contact information.

ZealTech Inc.
Phone:510.870.5025 * Cell: 510.449.5280 * Fax : 510.372.0571
ZealTech Inc.
Phone:510.870.5025 * Cell: 510.449.5280 * Fax : 510.372.0571

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