PROFESSIONAL SUMMARY:

Dedicated technical professional combines Master’s degrees in Management Information Systems (MIS) and Business Management with PMP, ITIL, business analysis and application development s. Strong background with SDLC deliverables, process improvements, change management; a sound understanding of the regulated space including FDA’s 21 CFR Part 11 compliance, audits, industry best practices (cGXP - GMP, GLP and GCP), software quality assurance (SQA) and computerized systems validation. Knowledge of PMBOK, PMLC and ITIL methodologies. Track record of success managing people, processes, and technology to produce high-impact client enterprise solutions on time and within budget.

PROJECT/PROGRAM MANAGEMENT EXPERTISE:

• Strategic Planning
• Relationship Management
• Cross-Functional Leadership
• Scope/Milestone Definition
• Process Improvements/ Reengineering
• Change Management
• Requirements Gathering
• Audits
• Quality Reviews
• Computerized Systems Validation
• Quality Systems
• Regulatory Compliance
• System Administration
• Configuration
• TW Project / Release Management
• Workflow Building
• Streamlining Processes
• Sparta Systems Trained

PROFESSIONAL EXPERIENCE:

Confidential, New Jersey

Practice Lead

Responsibilities:

• Provide consulting services to clients in the areas of: Project Management, CSV Projects, Regulatory Compliance and Audit Services.
• Provide Confidential services for Project Management, System Administration and Configuration, Workflow Building and Redesign, Streamlining Existing Workflows (BPR) and Business Analysis for Confidential .

Confidential, Rockville, MD.

Project Manager

Responsibilities:

• Manage projects leading cross-functional teams, following Confidential ’ PM methodology while leveraging general project management knowledge and experience.
• Administer, configure and design new/changed process workflows (system enhancements) in Confidential .
• Partner with business areas to ensure a smooth flow of operations.
• Build relationships and provide support/guidance as the IT PM for: Quality Assurance, Manufacturing, Regulatory - Clinical QA, Pharmacokinetic/Toxicology Groups
• Collaborate with System Owners, QA/Validation other IT groups to map out and deliver solutions for business problems and initiatives.
• Deliver business solutions in the form of IT systems with complex moving parts such as system architecture development, legacy systems migrations, testing efforts, process improvements and retirement planning.
• Project financial forecasting, rolling budget updates, reconciliations, periodic reporting and vendor relationship management.
• Conduct vendor/partner audits focusing on IT systems and compliance.

INDEPENDENT CONSULTANT/PROJECT MANAGER

Confidential, Washington, DC

Responsibilities:

• Manage/lead multiple projects through all phases of the project lifecycle.
• Analyze customer’s needs and leverage business analysis tools and methodologies to develop sound project strategies.
• Author solution documentation, including project scope, resource requirements, testing strategies, and application deployment/release plans.
• Manage vendor and customer relationships.
• Ensure compliance through the lifecycle of the project for clients in the regulated space.
• Overhauled business processes by integrating the lab equipment qualification and computerized systems validation processes for computerized lab systems while introducing a risk based approach to lab systems validation.
• Developed the procedures and the for the new processes; trained the user group on the same.
• Delivered significant cost and time savings by successfully managing the implementation of MasterControl (a controlled document management system) satisfying an important regulatory requirement.

Confidential, Cambridge, MA

Project Manager / Lead Specialist

Responsibilities:

• Managed cross-functional teams of 6-20 resources through all lifecycle phases for regulated/validation, management and reporting projects.
• Directed multiple projects with budgets in excess of $1M.
• Leveraged business analysis to evaluate business needs and defined solution strategy, project scope, milestones and deliverables.
• Documented requirements for interfaces, data migrations and workflows.
• Recruited, motivated, retained team members (internal and outsourced) also managed vendors and customers.

Confidential, New Jersey

Sr. Consultant /Project Manager

Responsibilities:

• Led project teams; mentored junior team members for the successful completion of multiple projects for multiple clients.
• Managed projects - ensured generation of SDLC deliverables and the timely completion of projects.
• Authored project deliverable documents including the Project Charter, Scope Document and the Project Management Plan.
• Developed the validation test plan, test cases and test procedure (IQ/OQ/PQ validation protocols/documents) using the business requirements document (BRD) and functional requirements document of the system for the qualification of multiple analytical instruments for a research facility.
• Managed a team of 6 for delivering the implementation of a BMS for Kemco Manufacturing. The BMS is a wide based, 3 module system vital for day to day operations. Achieved the completion of the project 2 weeks before schedule and 5% under budget.
• Managed planning and execution of disaster recovery testing to ensure operational readiness and business continuation of mission critical systems during natural disasters.