ROCCO ZAGAMI

* ******* ******, ********, ************* 02180

(H) 781-***-**** W (C) 617-***-**** W acw4x8@r.postjobfree.com

PROFESSIONAL SKILLS

11+ years of professional management experience in the Pharmaceutical/CRO Industry

Experience with Regulatory Compliance, FDA, 21 CFR Part 11 and GxP processes in a service delivery organization

Extensive experience with clinical trial documentation, terminology and regulations

Microsoft Office & Project w SAS Enterprise w PL/SQL Developer w Mercury Test Director

SDLC Methodologies – Waterfall and Agile

Quality - Experience with Standard Operating Procedures (SOPs) pertaining to Software Development, Validation and Change Control w CAPA Lead w Internal/External Audits

PROFESSIONAL EXPERIENCE

2012-2016 Director, Engineering - Production Services – PAREXEL International, Billerica, MA

Served as a key member of the management team of PAREXEL Medical Imaging (MI) Production Services, provided worldwide management and direction for MI projects’ charter and requirement specifications, application development, validation, support and maintenance

Worked with Managers within the organization to ensure timely, compliant and cost effective delivery of all project-specific software

Financial management including the development and monitoring of budgets and revenue recognition/forecasting

Represented Production Services during FDA and Client audits

Implemented resolutions to audit findings and Quality Issues/CAPAs, ensuring favorable future audits

Performed Lean Six Sigma on the overall software development lifecycle to ensure efficiencies in the application deliverables

Led software process development including the development of Standard Operation Procedures (SOPs), software testing and validation procedures and resource allocation

2008-2012 Associate Director, Software Quality Assurance – PAREXEL International, Billerica, MA

Managed, mentored and oversaw Software Validation Managers and Imaging Support Specialists worldwide

Responsible for client projects validation and production deployments

Directed software validation strategies for client projects to ensure quality of software developed and released and ensured its conformance with regulatory requirements related to validation of computerized systems

Managed creation of consistent validation documentation and a scalable approach to computerized systems validation

Represented Production Services during FDA and Client audits

Implemented resolutions to audit findings and Quality Issues/CAPAs, ensuring favorable future audits

Led software process development including the development of Standard Operation Procedures (SOPs), software testing and validation procedures and resource allocation

2007-2008 Senior Manager, Software Quality Assurance – PAREXEL International, Waltham, MA

2005-2007 Manager, Software Quality Assurance – PAREXEL International, Waltham, MA

Managed, mentored and oversaw Software Validation Engineer teams worldwide

Ensuring client satisfaction by sending a validated final data export in a timely manner

Devised and designed test strategies, test plans and test scripts to support project validation efforts

Reviewed and signed project requirements and other validation deliverables

Designed the Validation Plan, Test Plan, Traceability Matrix and Validation Plan documents

2004-2005 Senior Software Quality Assurance Engineer, Project Lead – BMC Software, Waltham, MA

QA Technical project lead for the Windows and Unix Patrol Performance Manager product

Identify testing needs, creating project and test plans

Managed and reported bugs in the Vantive database

Provided technical guidance to the QA group

Created weekly group status reports

Attended Project/Software Defect meetings and developed design meetings as the QA representative

Executed automation test sets using Perl and Silk

1999-2004 Software Quality Assurance Engineer - BMC Software – Waltham, MA

Created and maintained test scripts in applicable programming or scripting language

Provided clear, concise project and test documentation

Participated in documentation, development and improvement of processes and procedures

Accurately reported individual status to required levels of leadership/management

Designed and created test plans within area of responsibility

Wrote and executed test cases

1997-1999 Engineering Support Analyst – BMC Software, Waltham, MA

Coordinated/administrated individual beta programs for the ESM Business Unit

Developed beta/supplemental product documentation including test plans, install and implementation guides

Performed ad-hoc end-to-end testing on Perform/Predict

Performed customer site visits for the purpose of gathering product/business requirements

Provided technical assistance to sales in their pre-sales activities

1995-1997 Technical Support – Fidelity Investments, Securities Processing Group, Boston, MA

EDUCATION

2014 PAREXEL International training – Billerica, MA, Lean Six Sigma, Yellow Belt Certification

Certification of the fundamental methodologies utilized for Six Sigma

2004 BMC Software training – Waltham, MA, Linux System Administrator

Course provided the foundation concepts and practices for every Linux and Unix OS Administrator

1997 Northeastern University – Boston, MA, Division of Continuing Education, Introduction to Unix

1995 Salem State University – Salem, MA

Bachelors of Science in Business Administration, Concentration: Marketing

AWARDS

2015 PAREXEL International – Customer Satisfaction Champion

For unwavering commitment, loyal dedication and outstanding contributions toward goals

2007 PAREXEL International – High Performance Culture Award

Based on corporate values and represented by PAREXEL’s four principles and associated behaviors

2000 BMC Software – Product Management & Development Recognition Award

In appreciation and recognition of outstanding contribution and service during FY2000

Contact this candidate