Manager Quality

Denise Dugan-Bertussi, MBA

Grand Prairie, Texas *5052

201-***-**** • ************@*****.***

IT Project Management / Quality Assurance Management

** ****-**** ***** ****** of serving as liaison between business, quality, compliance,

and technical aspects of projects

Senior IT, Project Manager, Quality and Compliance professional, with experience in managing and coordinating major systems development and implementation projects. Sound experience in Project Management, Quality Assurance, Compliance, Audits, Information Security and Validation within the Information technology and pharmaceutical and medical device community. Broad knowledge across information systems development methodologies, risk assessment and gap analysis functions. Proven ability to quickly form good working relationships with employees at all levels. Talented and effective communicator. Excellent presentation, report writing, and prioritization skills. Core Competencies:

Full Life Cycle Project Management

Systems Launch / Implementation

Systems Procedure Auditing

Client Relationship Management

Agile and Waterfall Methodology

21 CFR, FedRAMP and MDSAP

Quality Assurance, Validation, Testing

Software Development Life Cycle

Quality Management Systems

Problem Resolution / Troubleshooting

User Training and Support

ISO 9000

Professional Experience

Verizon, Irving, TX 11/2016 – 7/2017

Program / Project Manager II

Oversaw auditing of multi-million Document Management System Program. Managed day-to-day running of the Program, including development and maintenance, against deadlines and in line with regulatory, quality and corporate requirements (ISO, CSV, SDLC, 21 CFR).

Spearheaded upgrade of the Document Management System Program, resulting in 75% reduction in document processing time the initial phase.

Initiated weekly conference calls between mid- and senior-level managers across the board to structure internal feedback system and improve quality of the systems.

Introduced documentation controlled archival which enhanced employee accessibility 24/7 online access to document repository with multi-leveled access system.

Alcon, Ft. Worth, TX 4/2013 – 11/2016

Senior Project Quality Manager/Assessor, Business Analyst, Auditor, Technical Writer

Governed under regulatory and quality requirements (SOX, GxP, cGMP, EMEA, ISO, CSV, SDLC, and 21 CFR). Planned, initiated, and managed quality management projects, from implementation to maintenance, compliance and financial accountability. Led and guided work of technical staff of 20 plus employees. Held full responsibility for budgets up to $15M. Analyzed business requirements, liaising with business and technical stakeholders as well as Global Product Surveillance department to review complaint investigations and handling. Monitored progress to assure deadlines, milestones, standards, and cost targets were met. Acted as primary contact and SME for internal customers to solve quality issues in a prompt manner.

Implemented and improved Global Quality Systems requirements within business unit groups across 25 IT projects ranging from Quality, R&D, infrastructure and implementation (LIMS, FourScore, DCM, RA Reader and Remedy).

Achieved with 100% completion of all assigned projects as scheduled or in advance.

CorePharma, Middlesex, NJ 11/2011 – 3/2013

Quality Assurance Documentation Manager

Directed all aspects of document systems administration, in line with regulatory guidelines. Managed 25-member team. Oversaw data mining as lead auditor on-site across international locations, ensuring compliance with US GxP regulations. Presented audit findings to C-level executives. Held Corporate Trainer role, delivering quality courses for internal audiences of up to 60 plus employees. Performed Gap Analysis as well as defined and managed solutions for pharmaceutical activities.

Configured EDMS Master Control encompassing MBRs, PBRs, SOPs, Change Controls, CAPAs, Specifications and Validation Protocols, from paper/electronic format in various programs and applications permitting 24/7 access to information for all stakeholders, based on access permissions.

Corporate Representative for integration of subsidiary policy and procedure uniformity

Developed remediation strategies, associated timelines, cost projections, risk assessment and project deviation for all non-conforming occurrences.

Mylan Inc., Morgantown, WV 12/2009 – 4/2010

Director Global Change Control, Global Quality

Led Corporate Global Change Control program, configuring, integrating and implementing solution across all Mylan locations: EMEA, NA, Asia, and EU. Analyzed quality and regulatory aspects in line with ISO, EMEA and FDA, acting as Quality Leader for integrating Global Standard Operating Procedures. Forecasted and produced monthly budget, based on project activities, resources and milestones, presented to executive Global Change Control Steering Committee on a monthly basis.

Developed and implemented validated database to support global integration, reporting, assessment of critical data and key performance metrics.

Developed Global TrackWise workflow to streamline electronic communication for all global facilities. Increased product delivery time by over 50% in initial implementation phase. Improved warehouse product transfer to additional facilities by over 60% in initial implementation phase.

PREVIOUS EXPERIENCE

Quality Assurance Documentation Manager (1/2007-12/2009), Quality Assurance Documentation Supervisor (2/2005-1/2007), Quality Assurance Coordinator (10/2001-2/2005) with Barr Pharmaceuticals, Pomona, NY as well as Regulatory Affairs Coordinator (9/1992-10/2001) with Lederle Laboratories, Pearl River, NY.

Education

Masters of Business Administration Global Management University of Phoenix May 2009

Bachelor of Science, Business Administration State University of New York June 2001

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