SUMMARY & GOALS

I have built a career of diverse skills that encompass science and management of information systems. My goal is to use this earned knowledge to facilitate effective partnership and leadership to implement technologies that improve business processes, allowing organizations to gain a competitive advantage over competitors. I have provided leadership in many dozens of projects, involving virtually all aspects of regulations and organizational structures. My passion for computerized systems validation has covered Finance, Payments & Accounts Receivable, Logistics & Supply Chain, Risk Management, Human Resources, Medical Devices, Bio Therapeutics as well as an abundance of scientific and statistical systems. As a CSV Specialist or Project Manager, I wish to leverage my experience and proficiencies to provide leadership in the evolution of corporate technologies.

EMPLOYMENT

BUSINESS SYSTEMS ANALYST

DrugDev, Wayne, PA

4/2016 – 5/2017

Partnered with key stakeholders to ensured business requirements are gathered and achieved efficiently

Translated business requirements into functional specifications for IT to implement system changes and upgrades

Designed configuration specification and optimized the flow of data supporting business processes

Through the creation of traceability matrices, ensured that all business requirements were delivered

Managed Test Plan and Test Script authoring to ensure end results met specified business requirements

Managed problem reporting and defect management to track issues and eliminate redundancies

Ensured knowledge transfer to business units by developing detailed training plans and support models

SENIOR VALIDATION SPECIALIST & Project Manager

CSL Behring, King of Prussia, PA

1/2012 – 4/2016

Lead the Validation effort for more than 20 IT Projects and used the experience to optimize QMS methodology

Authored multiple process improvements to global BT QMS methodology and documentation processes

Performed business process analysis to identify automation opportunities that could improve productivity

Authored global guidelines governing the selection and implementation of Cloud-Based solutions

Created an Application Platform methodology to govern leading edge technology implementations

Helped business partners to identify process redesign when automation alone could not provide improvements

Managed complex implementations and upgrade projects that were delivered mostly on-time and under budget

Promoted an honest sense of inclusion to garner trust and influence among stakeholders

As part of project proposal & approval, prepared detailed project plans to present to Steering Committee

Negotiated agreements between business unit(s) and IT to build requirements to enable an acceptable outcome

Promoted a culture of inclusion to effectively guide diverse teams in establishing goals

Coordinated globally diverse and virtual teams to sustain momentum and a shared involvement

Passionately energized focus while maintaining an empathetic awareness of different opinions

When necessary, leveraged earned authority to tactfully persuade project direction

SENIOR RISK MANAGEMENT ASSOCIATE

Endo Pharmaceuticals, Chadds Ford, PA

3/2011 – 12/2011

Responsible for emerging the regulatory compliance of IT Division within the Endo Enterprise

Authored Global IT Quality Policy to facilitate to acquisition of companies, Medical Devices, Bio Therapeutics

Managed Computer System Validation (CSV) process for the Endo Enterprise

Endo Pharmaceuticals, Chadds Ford, PA Continued…

Provided Quality review and approval for high-risk implementations

GxP Change Manager for Global IT Applications, Pharmaceutical, Medical Devices, Bio Therapeutics

Authored all types of CSV documents, Medical Devices, Bio Therapeutics

Managed IT personnel training and compliance initiatives

Managed Change Management (CM) process for Computerized Systems for the Endo Enterprise

Managed IT Change Management Processes for the Endo Enterprise

User Administrator for Service Now Change Management/Problem Reporting Software for IT personnel.

User Administrator for Plateau e-Learning Application

SR. QA ASSOCIATE I (E-SYSTEMS)

Dendreon Inc., Morris Plains, NJ

4/2010 – 3/2011

Quality Manager for the global IT Infrastructure Qualification for US Manufacturing Site Expansion

QA oversight for exception reporting (Event Reporting/Deviation) investigations related to e-Systems

Provided QA approval for Change Controls/Change Management related to e-Systems

Authored and Implemented CAPA Plans related to e-System deviations (i.e.- Business Continuity Planning)

Revised and/or authored SOPs and Work Instructions & Risk Assessments

Provided Training for SOP creation and/or revision

Developed QA Super-User Program for Oracle ERP System

Assisted in Vendor Selection and User Requirements for a multitude of electronic system alternatives

DEPARTMENTAL QUALITY ASSURANCE SPECIALIST & E-SYSTEMS PROJECT MANAGER

CSL Behring, Malvern, PA

5/2007 – 12/2009 (Overlap with previous position)

User Administrator/Project Manager for a Global Chromatography Data System Implementation

Ensured the on-time delivery of goals, within budget and compliance

Validation Team Functional Manager (Users, QA and IT).

Ensured the compliance of Data System(s) & Managed throughout Life Cycle

Authored and/or approved quality documentation: SOPs, User Requirements, Validation Plans, Operational Qualifications (OQ), Installation Qualifications (IQ), Installation Procedures, User Acceptance Testing (UAT) Scripts, Traceability Matrix, Deployment Plans and Routine Maintenance Procedures

Managed IT budget for Analytical Sciences Department

Managed Change Controls & Risk/Impact Assessments related to departmental Information Systems

SENIOR RESEARCH INVESTIGATOR

CSL Behring, Malvern, PA

12/2000 – 10/2007 (Overlap with subsequent position)

Developed analytical methods to support pre-clinical development of Drug Substances and Drug Formulations

Managed Laboratory Contract Staff

ANALYTICAL CHEMIST

Various Companies (Both Pharmaceutical & Non-Pharmaceutical, Greater Philadelphia Area

1995 – 2000

Contracted mostly through Scientific Staffing Incorporated

IBAH Pharmaceutical (On Staff), Merck, Dupont Merck, McNeil Consumer Products, Astra Zeneca

EDUCATION

Eastern University,

-Bachelors of Science Degree in Management of Computer Systems, 2011

Drexel University (Chemistry & Biology)

Salisbury State University (English & Philosophy)

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