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

WORK PERFORMED:
¨      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.



REQUIRED SKILLS & KNOWLEDGE:
¨      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.

DESIRED BACKGROUND & EXPERIENCE
¨      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.


 
Thanks,
 
Sonali
ZealTech Inc. 
 
Phone:510.870.5025 * Cell: 510.449.5280 * Fax : 510.372.0571
 
  
  

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