Manager

KARI E. HULGAARD

** ****** **** *****, ******, CT 06801

TEL: 203-***-**** EMAIL: ************@*****.***

INTRODUCTION

IT project management and validation/quality specialist with 15+ years of experience in various business and IT areas. Focus on project management, leadership, communication, customer service, quality and relationship management.

PROFESSIONAL EXPERIENCE

Owner 2011 – Present

Company: Kindness is Contagious

• Provide solutions to appreciation marketing for individuals, employees and customers.

Principal Consultant 2010 – Present

Company: Pharma Veritas Consulting

• Provide services for computer system validation, system/process audits and quality management system design, implementation, maintenance and updates, as well as end user training.

Project Manager 2006 – 2010

Title: Project Manager, Information Systems

Company: Progenics Pharmaceuticals, Inc., Tarrytown, New York

• Collaborate with internal business customers to develop and/or improve business processes.

• Develop and implement quality and regulatory systems with the Quality Assurance team.

• Manage system related budgeting, contracts, licensing, and system related purchasing.

• Deliver project reporting, metrics and budget updates to senior management.

• Manage overall system changes, including configuration changes, infrastructure changes, software configuration changes, upgrades and data migrations, using System Development Lifecycle (SDLC) practices and formal Change Management controls.

• Manage business projects from initiation to implementation, and ongoing use for controlled business processes with a concentration on quality, clinical and regulatory business processes.

• Manage and perform computer system validation testing.

• Perform periodic surveys from business customers and user community discussion groups.

• Conduct for all aspects of system, administrator and end user training, and generate associated deliverables.

• Deliver compliance related policies and processes to support IT and business operations.

• Develop business process maps, and gather system and user requirements.

• Develop and maintain validation documentation to ensure the continued validated state and integrity of system.

• Develop and implement data migration, change management, system maintenance, disaster recovery and business recovery processes.

• Provide daily application support by advising and assisting clients in the use of system.

Quality Assurance and Compliance Program Management 1999 – 2005

Title: Senior IT Quality Support Analyst Information Technology, 2002 – 2005

Title: Project Analyst, 1999 – 2002

Company: Purdue Pharma L.P., Stamford, Connecticut

• Manage steering committee for Information Technology compliance program to deliver consistency and streamline processes for compliance and business controls.

• Develop international System Development Lifecycle and Project Management methodology.

• Develop and deliver application training program for international document management system.

• Develop and implement compliance training program which met and maintained a goal of 100% compliance for an international customer base.

• Manage core project teams for site Standard Operating Procedures (SOPs) to support IT with a focus on process improvement, compliance and reduced approval cycle time in conjunction with Project Quality Office objectives.

• Deliver compliance training on SOPs, System Development Lifecycle and current Good Manufacturing Practices (cGMPs).

• Implement electronic document management system for compliance critical documents to international user base.

• Establish and maintain a controlled document central archive facility.

• Develop and implement curriculum and electronic training materials for introduction to cGMP business environment.

• Perform audits and assessments on SOP processes in order to assess and report compliance to internal controls.

• Develop and implement an assessment package for use on IT systems to enable system administrators to perform assessments to internal controls.

• Design and maintain processes and forms to assist in the implementation of various projects, such as an SDLC methodology and enterprise-wide project management tools to ensure consistency in documentation and process delivery.

• Establish testing standards and scripts to facilitate year 2000 steering committee directives, including disaster recovery testing.

Systems Administration and Submission Support 1994 – 1999

Title: Systems Administrator, Regulatory Affairs, 1996 - 1999

Title: Secretary, 1994 - 1996

Company: Purdue Pharma L.P., Norwalk, Connecticut

• Prepare and file submission documentation with various international boards of health.

• Coordinate drug listings with Drug Enforcement Administration (DEA) for controlled substances.

• Coordinate the development of Company standards for Microsoft Word electronic document formatting.

• Develop and deliver training program for electronic regulatory submission documentation.

• Develop Standard Operating Procedures for computer systems to establish support and operational procedures.

• Perform Application and System Administration duties for drug safety system, including change management and validation practices.

• Assist in the development and implementation of Company’s first formal Computer System Validation model and document development.

• Develop systems disaster recovery program for Regulatory Affairs to ensure efficient and timely recovery of critical systems.

TECHNICAL SKILLS

Develop business and compliance documentation such as Policies, Standards and Standard Operating Procedures. Develop technical documents such as protocols and SDLC documents. Develop and perform validation testing for GMP systems. Deliver process and compliance based training. Develop business process mapping and design. Generate user and administrator based application manuals and FAQ library.

TOOLSET PROFICIENCY

Microsoft Word, Excel, Outlook, Project, PowerPoint, PeopleSoft, RoboHelp, TrainerSoft, Documentum, Sharepoint, Argus Safety, SAP, WebEx and e-DocCompliance (QUMAS).

Computer System Validation, including Functional, Integration, Performance and Security Testing, Prince II (UK-based project management methodology) and regulatory submission electronic document formatting requirements.

INDUSTRY BACKGROUND

Current Good Manufacturing Practices, Good Laboratory Practices, Good Clinical Practices,

Electronic Signature Guidance, System Development Lifecycle (SDLC) various methodologies,

Good Automated Manufacturing Practice (GAMP), Project Quality Model and

Sarbanes-Oxley Act (SOX).

EDUCATION

BA, English Composition, SUNY Potsdam, Potsdam, NY, 1989

BUSINESS TRAINING

Business Writing

Dynamics of Teams

Ethical Awareness and Decisions

Interpersonal Communications

Leading Project Teams

Managing Conflict

Managing Multiple Priorities

Presentation Skills

Project Management

Selling Your Ideas

System Development Lifecycle

INDUSTRY TRAINING

Advanced Validation Training

Change Management

Drug Safety System Training

Electronic Document Management

Fundamentals and Essentials of Validation

GAMP

Good Clinical Practices

Good Laboratory Practices

Good Manufacturing Practices

IEEE

ISPE

IT Risk Management

Prince II

Six Sigma

Writing SOPs

MEMBERSHIP

Drug Information Association (DIA)

Parenternal Drug Association (PDA)

Pharmaceutical Education and Research Institute (PERI)

LANGUAGE / INTERESTS

Speak Danish Fluently

Language Training in French and German

Perform Technical Translation Certifications

Singing and Stage Performing

Charity Fund Raising

Teaching Violin

Traveling

OTHER EMPLOYMENT HISTORY

Teach ESL at Clarkson University, Potsdam, New York

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