SUMMARY:

Senior level Project/Program Management Professional with extensive experience in enterprise PMO and Program Management in the pharmaceutical, energy and insurance sectors. Highly skilled in developing framework and methodology to position PMO as a consultative value - added service. Proven track record of successfully managing a wide variety of large-scale strategic and tactical projects across all functional areas in both regulated and deregulated markets. Confident, results-driven leader with exceptional communication and interpersonal skills committed to collaboration and continuous improvement with end goal of excellence and the delivery of high quality product. Experienced in strategic planning portfolio managementand strategic alliance in vendor management, system design and development of virtual teams with integration of offshore resources.

PROFESSIONAL EXPERIENCE:

Confidential, Plymouth Meeting, PA

BUSINESS ANALYST - DATA GOVERNANCE

Responsibilities:

• Served as project interface with project stakeholders. Responsible for facilitating delivery of SAP customer-defined software development within business glossary project
• Managed and assisted the product owner and business analyst with managing SAP governance and backlog
• Removed all obstacles to project team efficiency and effectiveness; reached out to the larger organizational network for impediment removal; ensured cross-team coordination
• Worked with SAP development teams during beta testing, customer validation, and release phase to ensure consistency across teams
• Provided product development process guidance, including data profiling, data cleansing, and reporting to project team and cross-functionally within department
• Identified and implemented targeted improvements to work instructions and forms within product development process
• Led functional business participation in metadata management activities including the establishment of data definitions, and business rules for data transformations
• Formulated and defined system scope and objectives through research as well as an understanding of the applicable business systems, industry standards, and best practices
• Worked with database architects and developers to aid in building more robust database infrastructure to increase process efficiency
• Defined and executed the SAP business metadata management program including definition of a trusted business glossary and metadata repository to be used throughout the organization
• Collaborated with Data Owners and Business Data Stewards across the organization to develop a common vocabulary and semantic layer

Confidential, Newark, DE

PROJECT MANAGER - COMPLIANCE

Responsibilities:

• Provided all aspects ofprojectmanagement, including detailedprojectrequirement definition, budgeting,projectplanning, metrics tracking, and timely deliverables to ensure successful end to end execution of theproject.
• Identifiedprojectrisks and issues, escalated majorprojectrisks to scope, budget, and timeline to appropriate escalation points. Analyzed the business risks and opportunities on a monthly basis to provide information to management
• Successfully migrated more than 25 projects from Waterfall to Scrum within 6 months
• Directed the preparation for compliance audits as well as internal spot checks for compliance processes and controls
• Conducted focus group meetings/interviews with subject matter experts to identify their needs and translate them into procedures
• Ensured adherence of established formats, standards, and governing policies and procedures for approval
• Recommended solutions to correct procedure sequencing and structural deficiencies, gaps and/or omissions
• Communicated and advocated new and/or improved procedures
• Managed and maintained the procedures review process including periodic review and situation condition changes
• Served as a business liaison between business groups and IT administrators and offered suggestions for document management methods

Confidential, West Chester, PA

PROJECT MANAGER - DOCUMENT CONTROL

Responsibilities:

• Managed and planned at the portfolio level that included tracking of actuals and accruals, month end reporting and variance analysis and reconciliation with finance during budgets and projections.
• Implemented innovative and creative solutions to strengthen internal controls, increase data accuracy, and improve efficiency/effectiveness of organization.
• Managed documentchange control process to include working directly with authors, reviewers, and approvers to facilitate document and change order workflow; assisted with document formatting; ensured proper documentorganization; ensured required metadata and other applicable data inputs for compliance were provided; and tracked open tasks to facilitate timely turn around.
• Led quality control activities and collaborated with Quality Control auditors to manage the level of submission documents
• Managed document control/management system to ensure the appropriate storage and retrieval of high quality documents
• Generated and assessed quality measurement metrics to ensure standard quality control levels were maintained
• Compared language in each document for consistency with other documents containing similar subject matter
• Followed up as necessary to ensure that documents were moving through the system in a timely manner
• Developed and implemented document and change control processes to ensure compliance with FDA regulations and CAPAs to support business needs

Confidential, Exton, PA

PROJECT MANAGER - DOCUMENT CONTROL

Responsibilities:

• Partnered with organization team members and clients to support business-technology plan.
• Assessedprojectissues and identified solutions to meet productivity, quality and customer goals.
• Ensured effective change management processes were in place to ensure smooth implementation and transition of business change.
• Conducted QC reviews, verified data against approved sources of document deliverables including PSURs, RMPs, responses to regulatory authorities, labels, and submission components such as SCS and SCE that ensured accuracy and internal consistency
• Provided ongoing analysis of data resulting from the quality review of document deliverables
• Collaborated with Regulatory Affairs and other departments to prepare clinical sections for annual IND updates, IND submissions, and submissions to regulatory agencies
• Wrote and maintained master files and archives files for the following records: Master Batch Records, Analytical Test Methods, Standard Operating Procedures, Raw Material Specifications, and Training Curricula
• Processed all approved Document Change Requests, ensuring that all controlled documents were created following the applicable format

Confidential, New York, NY

SENIOR BUSINESS ANALYST

Responsibilities:

• Leveraged business relationship management skills and the ability to understand and anticipate the needs of the business stakeholders.
• Ensured that proposed solutions were focused on improving efficiency and effectiveness of the business processes, and were consistent across products and services.
• Led software product development teams through all phases of new product development and existing product improvement from initial concepts through launch, for multiple complex and/or interdependent projects simultaneously
• Provided product development process guidance to project team and cross-functionally within engineering department
• Identified and implemented targeted improvements to work instructions and forms within the product development process
• Benchmarked best product development practices within the industry and at other operating companies, and implement on projects as appropriate
• Developed and maintained detailed work plans, schedules and cost plans for projects
• Reported project status within the engineering department and to cross-functional stakeholders: proactively as appropriate, at scheduled review meetings and at the Product Planning Group
• Represented project activities during audits, both internal and external (FDA, ISO, etc.)
• Provided oversight for development and completeness of project requirements (user needs and use cases, design inputs)

Confidential, Blue Bell, PA

BUSINESS ANALYST/TECHNICAL WRITER

Responsibilities:

• Developed detailed project plans for multiple simultaneous projects, resulting in increased visibility of inter-project dependencies and improved development efficiency
• Identified project risks. Designed and implemented project status reports and communications
• Developed and organized departmental technical documentation including standard operating procedures (SOPs) and user guides
• Managed life-cycle implementation and led multiple continuing critical activities in process-oriented environment
• Wrote functional and design specifications required by auditors to ensure existing documentation met FDA guidelines, including CFR 21, PT. 11