Business Analyst Project Manager

Eric M. Gunther

Hillsborough, NJ ***** ************@*****.*** linkedin.com/in/ericmgunther

SUMMARY

Results-driven Senior Project Manager, Technical Business Analyst, Quality Software Developer and Validation Expert with over 20 years of experience in the pharmaceutical and life sciences industry. Specialized in end-to-end automated Quality Management Systems (QMS) and regulatory compliance systems.

Proven track record of leading global software implementations across 70+ sites, collaborating with business leaders to define requirements, prototype solutions, and drive successful systems to production. Skilled in Agile and Waterfall validation methodologies, documentation, testing, training and system enhancements.

Expert in project management, resource allocation, and budgeting, ensuring on-time delivery of multi-million-dollar initiatives. Adept at presenting project milestones to senior leadership, optimizing workflows, enhancing regulatory compliance and problem solving.

EDUCATION

Bachelor of Science in Chemical Engineering

Manhattan University, Riverdale, NY 1999

SKILLS

●Senior Project Manager

●Validation Expert in Waterfall and Agile (Scrum Master Certified)

●Senior TrackWise and Crystal Reports Developer

●Validation Expert in Waterfall and Agile (Scrum Master Certified)

●Senior Technical Business Analyst

●Extensive Experience Collaborating between Upper Management and Department Heads

●End-to-End Implementation of Quality Assurance Software Solutions

Quality Management Configuration and related Software Validation Deliverables Include:

●Corrective and Preventative Action (CAPA) System

●Customer Complaint and Field Alert Reporting System

●Out of Specification (OOS) Quality Control Investigations

●Quality Event Reporting System (Non-Conformance and Deviations)

●Internal and External Audit Management and Change Control Management System

●Experience with Azure, SharePoint, Jira, Google Cloud, Python, AWS

●Regulatory Submission Planning Applications

●Document Management and Training Management Solutions

●Deviation and Investigation Reporting

PROFESSIONAL EXPERIENCE

Consolidated Computer Resources, Matawan, NJ

Senior Project Manager and Software Developer Jan 2023 – Present

●Led the validation documentation process for a $1.5 million Global Regulatory Compliance tracking system, ensuring full compliance with FDA and EMA regulations.

●Successful launch included Validation Plan, Requirements Doc, Functional and Design Specifications, Software Configuration, and UAT test scripts.

●Trained and mentored 5+ offshore developers, improving TrackWise configuration efficiency and reducing defects in Crystal Reports.

IQVIA, Tampa, FL

Senior Project Manager and Technical Business Analyst July 2019 – November 2022

●Managed 8+ projects simultaneously, including planning, scheduling, and resource allocations to meet customer requirements. Achieved less than 10% variance of planned schedules and budgets.

●Analyzed and documented business processes, improving workflow efficiencies and reducing process inefficiencies across multiple departments.

●Worked with cross-functional teams to document technical requirements for software integration, improving operational efficiency for IQVIA SmartSolve, TrackWise, and TrackWise Digital.

●Conducted in-depth data analysis that improved regulatory compliance reporting accuracy, reducing audit risks.

●Mentored and motivated a team of 5 junior analysts, maximizing productivity and issue resolution.

Teva, North Wales, PA

Project Manager and Technical Business Analyst Mar 2018 – June 2019

●Lead Analyst and Developer for global QMS Harmony CAPA system across 70 global sites, reducing CAPA processing time and ensuring full regulatory compliance.

●Designed and implemented automated validation deliverables in QC software for FDA compliance and audit preparation.

Pfizer, Peapack, NJ

Project Manager and Software Developer Feb 2011 – Feb 2018

●Led enhancement of Submission Planning (SPA) and Regulatory Commitment Tracking, reducing submission processing time over fifty percent.

●Spearheaded Quality Tracking software implementation, writing user requirements and UAT scripts that improved system usability.

●Led multi-departmental customer workshops to define project objectives and business cases.

●Managed requirements gathering, data mapping, and process documentation to ensure compliance with Pfizer’s business objectives.

●Led 10+ successful data migrations using AQL monitoring, ensuring complete regulatory compliance.

●Scrum Master for global Complaint Intake, Triage and Investigation (CITI) software system across 70+ sites, replacing outdated systems and harmonizing process across all sites worldwide.

Bristol-Myers Squibb, Hopewell, NJ

Software Developer and Technical Business Analyst August 2009 – Jan 2011

●Led major upgrade of Global Quality and Regulatory Compliance (GQRC) Systems, optimizing automated quality system functionalities.

●Developed automated trend and metrics reports for Health Authority Commitment Management (HACM), driving improved audit efficiency.

●Authored critical validation docs for global regulatory submission, ensuring FDA and EMA compliance.

●Conducted pre-FDA audit validation review, identifying and fully remediating 15+ compliance gaps.

Takeda Pharmaceuticals Inc., Chicago, IL

Software Developer and Technical Business Analyst June 2007 – July 2009

●Led TrackWise QMS upgrade across multiple sites, integrating custom Crystal Reports.

●Developed technical design documentation and 30+ System and UAT Test Scripts, ensuring 100% validation compliance.

URL Mutual Pharma, Philadelphia, PA

Software Developer and Technical Business Analyst June 2006 – June 2007

●Led requirements analysis across 4 departments for Change Control and Quality Incident Reporting initiative, improving efficiency and compliance.

●Installed and configured Quality Control software for 7 departments, training of 80+ users.

Abbott Laboratories, Inc., Edison, NJ

Automated Quality Systems Administrator March 2003 – May 2006

●Automated Quality Software workflows for deviations, investigations, and customer complaints, reducing manual workload by 50%.

●Led data migration efforts for numerous legacy systems, ensuring 100% data integrity.

●Received ‘Spirit of Innovation’ award for leading enterprise-wide validated automated systems, improving company efficiency by 40%.

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