Project Manager Resume

SUMMARY:

Over twenty - five years of information systems experience including 20+ as a consultant specializing in project director/management, PMO and SDLC strategies development and management, SAP (OTC, SD, WM, CRM) business and practice development/management, account management and regulatory practices and program development.
Specialize in the successful execution of on-time, on-budget delivery of validated life sciences and consumer products projects per FDA/SOX/Euro regulations.
Experience includes the successful implementation of SAP, integrated applications, ERP and custom business software solutions utilizing the full system development life cycle. SAP certified Sales & Distribution and ASAP consultant.

EXPERIENCE:

Project Manager

Confidential

Responsibilities:

Responsible for project execution including, resources, project plans and finances, issue resolution, status reporting etc.
This is a 5 site, 4 phase project with ~130 team members and included but was not limited to SD, QM, TM and EWM functionality.

Program Director

Confidential, Bridgewater, NJ

Responsibilities:

Develop project management consulting delivery/management practice for a strategic Confidential .
The practice included upgrades and implementations of SAP ERP and SAP S4 Hana.

Project Manager, Regulatory Lead

Confidential

Responsibilities:

Implement and validate the desktop release 8.0 of Sensitech’s temperature monitoring system.
This implementation would be further rolled out as the system template across the organization.
Responsible for all aspects of project execution including tasks & vendor relationships.

Project Manager

Confidential

Responsibilities:

During the acquisitions lifecycle, managed & executed the integration of Quality Management Systems into the acquiring organizations systems & QMS operating environments.
Also execute required validation, archiving and decommissioning activities.
Responsible for the daily execution of scheduled tasks, resources/tasks distribution & budget tracking

Principal

Confidential, Bridgewater, NJ

Responsibilities:

Implementation PM for a Global harmonized fully validated, SAP solution to over 10,000 end users in 8 global locations.
Responsibilities included the direction & coordination of all teams including; Functional, Development (on/off shore), Security, Change Management,, D Confidential Migration. Participated in the Stakeholder, Steering Committee, Board and Leadership meetings.

Confidential

Project Manager

Responsibilities:

responsible for the cut over of SAP supply chain process improvements, modifications and implementations.
Projects included implementation of a validated document management system and modifications to the SAP 6.0 system realizing process improvements and new function utilization.
Responsible for all aspects of SOX and GxP regulations during this fully validated project utilizing the organizations SDLC.
Regulatory Lead for validated implementations of Swisslog’s WMS system at 6 distribution facilities.
Project Manager and Validation Lead for the cut over of multi-site SAP Plant Maintenance implementations.
Responsible for the management and execution of 6 plant maintenance roll outs including validation,, d Confidential conversion and testing.

Confidential

Regulatory Team Lead

Responsibilities:

responsible for the FDA/SOX validation of an ECC 6.0 domestic SAP R/3 implementation.
Responsible for change control, testing (HPQC) and documentation review processes.
Also, responsible for the development of validation strategies and execution for audit trail and electronic signature requirements.

Confidential

Consulting Project Manager

Responsibilities:

responsible for the implementation and FDA/SOX validation of a $75 (mil) OTC domestic SAP R/3 (4.6C), Model N and Edge Dynamics implementations.
Project included development and approval of all required regulatory documentation. responsible for the implementation of SAP to integrate 10 European countries into the companies SAP production instance.
These were SAP R/3 (4.6C) implementations including full suites of validation requirements and documentation.