Summary
Overview
Work History
Education
Skills
Certification
Affiliations
Accomplishments
Timeline
Generic
Gary Ugarek

Gary Ugarek

Palmerton

Summary

Dynamic Quality Systems Consultant with extensive experience at Hikma Pharmaceuticals, specializing in regulatory compliance and project management. Proven track record in implementing Veeva Vault and enhancing operational efficiency. Adept at leading cross-functional teams and driving change management initiatives, ensuring inspection readiness and compliance with CFR regulations.

Overview

30
30
years of professional experience
1
1
Certification

Work History

Global GMP Applications IT Portfolio Project Manager (Contractor)

Hikma Pharmaceuticals via Devfi systems
12.2024 - 05.2025
  • Developed detailed plans for projects based on customer needs and expectations.
  • Implemented corrective action plans when necessary due to unexpected delays or obstacles encountered during construction activities.
  • Developed solutions to project risks and issues, meeting quality and timeline goals and objectives.
  • Made changes to project scope and cost and implemented most effective change management processes to keep project up-to-date.
  • Managed cross-functional teams to ensure project alignment with company objectives.
  • Developed project plans and schedules using industry-standard tools and methodologies.
  • Facilitated stakeholder meetings to gather requirements and address concerns effectively.

Senior Manager, Quality Systems (Consultant)

Sharp Packaging Solutions
09.2023 - 04.2024
  • Provide oversight and strategy for the Quality Assurance group, and all quality systems for post-market surveillance and pharmacovigilance.
  • Developed strategic plans to enhance operational efficiency and productivity.
  • Led cross-functional teams to implement process improvements and best practices.
  • Collaborated with external vendors to negotiate contracts that met company requirements while minimizing costs.
  • Facilitated training sessions to improve staff skills and knowledge retention.
  • Oversaw compliance with industry standards and regulatory requirements in operations.
  • Managed a team of 10+ employees by providing guidance, setting goals and objectives, delegating tasks, and monitoring performance.

Oxford Global International
03.2022 - 08.2023
  • Deployed Veeva Vault eQMS program for documenting quality events, CAPA, LIR, root cause analysis, change management, and document control.
  • Led deployment of Veeva Vault eQMS/LIMS at Pfizer, overseeing document configuration and process exercises.
  • Managed communication within PDO group to ensure project alignment and efficiency.
  • Developed LIR project tracker with timelines aligned to project kick-off.
  • Participated as a member of the Process Configuration team to define roles and responsibilities.
  • Created training documentation and work instructions for effective user onboarding.
  • Assisted in drafting LIR deployment plan and security matrix to optimize project execution.
  • Conducted user acceptance testing, test case execution, and regression testing for various eQMS projects.

GMP Medical Device Quality Systems Implementation Director (Consultant)

HemaTechnologies (Formerly Air Scan Inc.)
02.2019 - 04.2023
  • Delivered training and consulting services for Class 1 Medical Device Manufacturer preparing for FDA compliance audit.
  • Led development of eQMS systems, including Veeva and Service Now.
  • Ensured inspection readiness by training employees and conducting mock audits.
  • Implemented fully compliant CFR 820 Quality System with established processes for non-conformance, CAPA, and supplier quality approval.
  • Coached staff individually to manage stress related to operational changes.
  • Facilitated weekly team meetings to gather feedback on productivity impacts from new Quality System.
  • Authored over 250 new quality-controlled SOPs, work instructions, and governance documents.
  • Prepared simulation of FDA audit readiness, enhancing document and response preparedness.

Consulting Services Manager

Accenture North America
01.2020 - 05.2022
  • Led consulting teams to develop strategic solutions for client challenges.
  • Facilitated workshops to enhance stakeholder engagement and collaboration.
  • Analyzed client processes to identify areas for improvement and efficiency.
  • Mentored junior consultants in best practices and project methodologies.
  • Presented findings and recommendations to executive leadership teams.
  • Managed client relationships to foster trust and long-term partnerships.
  • Ensured compliance with applicable laws regulations when providing consulting services.
  • Created reports summarizing project status, findings and outcomes for clients' review.

GCP, GMP Quality Systems Remediation Consultant

Recordati Rare Disease Group, North America
Lebanon
07.2019 - 10.2019
  • Delivered full-time consulting services for small virtual Rare Disease Biologics group in Lebanon, NJ.
  • Served as QMS lead expert for Veeva Vault Quality Docs.
  • Acted as prime system administrator during Vault and QMS implementation.
  • Oversaw processing of system changes to enhance functionality.
  • Aligned system configurations to address process gaps effectively.
  • Utilized Agile and Scrum methodologies to guide implementation activities.
  • Led Quality System upgrades to comply with CFR 210/211, ICHQ7A, Health Canada, and EU regulations.
  • Reorganized Supplier Program to improve oversight of CMO contracts for API and BDS manufacturing.

FBS Master Control Implementation Project Manager

Tissue Tech Inc.
Doral
05.2018 - 12.2018
  • Providing expertise and consulting services for the implementation of full Master Control suite V 11.5 for a conversion from GTP to GMP Medical Device/Tissue based pharma client out of Doral Florida.
  • Analyzing the implementation through 2 phases, Master Control standard suites 11.5 and FBS product modules 11.6 – 11.7.
  • Driving a successful implementation through thorough selection and procurement of Configuration specialists, as well as junior business analysts to perform the data gathering functions to successfully implement Master Control eQMS product Suite.
  • Implementation and configuration of standard OOTB Master Control Suite 11.5.
  • Led project planning sessions to define implementation strategies and timelines.
  • Managed stakeholder communications to provide updates and address concerns promptly.
  • Facilitated meetings to gather requirements and document client specifications accurately.
  • Oversaw software configuration processes to meet project goals and user needs effectively.
  • Applied extensive expertise in System Development Lifecycle (SDLC) methodologies and Agile project management techniques to manage multiple project teams.

Senior Quality Professional/Manager/Director

CONSULTING SERVICES for Multiple Organizations
01.2011 - 04.2018
  • Delivered Veeva Quality Systems implementation for Oncolytics Biotech within project timelines.
  • Managed GxP quality systems implementation during clinical trials at Immunomedics.
  • Acted as process quality manager consultant for batch disposition at Pfizer, ensuring compliance.
  • Led upgrade project as senior PTC Windchill process owner at Philips Healthcare.
  • Oversaw supplier quality management and batch disposition processes at Teva Pharmaceutical.
  • Directed Trackwise DVCS implementation as business process manager at Zimmer.
  • Served as system administrator and implementation manager for ETQ at McNeil Consumer Healthcare.
  • Conducted recall investigations as lead engineer at Depuy Synthes, improving safety protocols.

Compliance Specialist II

MedImmune, LLC
Gaithersburg
10.2004 - 10.2010
  • Company Overview: A clinical and commercial biologic manufacturer based out of Gaithersburg, MD, specializing in Phase I-III clinical drug manufacturing, release, and trials.
  • Team member for the $250 million-dollar Pilot Facility design, flow, and compliance program.
  • EQMS Superuser and implementation volunteer for Trackwise DVCS, Aegis Document Management System, and SharePoint implementation.
  • Selected Project Accomplishments:
  • Perform facility audits monthly determined by pre-defined schedule.
  • Evaluate and monitor Aseptic processing areas.
  • Perform Nonconformance investigations for Quality and Manufacturing System failures and Manage CAPA remediation programs.
  • Serve as a member of the internal QRB and CRB.
  • Perform essential QA on the floor/Compliance on the floor facility inspections of Lab and Manufacturing Areas.
  • Evaluated failures of change control remedies.
  • Determined deviation impacts on manufacturing processes during triage and disposed of quarantined materials.
  • Address findings within FDA issued Warning letters and/or Consent Decree Obligations.
  • Documented workflows and created comprehensive training plan after manufacturing team audit revealed 483 findings of training and performance deficiencies.
  • Used ADDIE techniques to introduce training programs in SOPs, auditing, and other multi-use quality system programs and processes.
  • Implement Quality by Design Principles lead remediation activities for CAPA Programs, Validation Activities, Lab Protocols, and Manufacturing Process redesign.
  • De-commission of original licensed facility located @Watkins Mill Rd in Gaithersburg.
  • Assist process engineering with the commissioning of the 6 floor, 300,000 sq ft. Pilot facility built in 2006.
  • Administrate and train users on the batch Processing system through Windows 2003 Server terminals.
  • Perform weekly New Employee compliance orientation.
  • Management of the Manufacturing LO/TO program as a member of the EHS team.
  • Develop training programs and modules for the Compliance Wire LMS system.
  • Issue and Track all Equipment and Room use logbooks.
  • Perform and Track Batch Disposition of Commercial and Clinical Manufactured FDP.
  • Review and approve all clinical trial batch processing records and solution preparation records.
  • Mentor 4 junior associates.
  • Maintain all GMP manufacturing records.
  • Facilitate Change Management programs.
  • Clinical and commercial biologic manufacturer based out of Gaithersburg, MD, specializing in Phase I-III clinical drug manufacturing, release, and trials.

Quality Systems specialist II CMO program

Cambrex Bio Sciences
01.2004 - 10.2004

Quality Systems Specialist Bulk Liquid Manufacturing

Alpharma USPD
12.2002 - 11.2003

ISO 9001 Automotive Supplier Quality Engineer

East Penn Manufacturing
05.2000 - 07.2002

ISO/QS 9000 Automotive Quality Engineer

Chicago Rawhide SKF
03.1998 - 04.2000

Finished Product Quality Assurance

John Harland Check Printing
07.1995 - 02.1998

Education

Bachelor of Sciences - Business Administration/Sciences - US

New York State University
New York, US

Some College (No Degree) - Information Technology (IT)

University of Phoenix
Remote

Skills

  • Regulation Compliance
  • Final Drug Product Release
  • Compliance Auditing
  • Batch Review/release
  • Deviation/CAPA
  • Pharmacovigilance
  • Veeva Vault
  • Trackwise
  • ETQ Deployment
  • PTC Windchill
  • Written Communications
  • Quality System Management & Implementations
  • GxP Compliance
  • Project Life Cycle
  • Technical Writing
  • Process Development/Improvement
  • Sterile/Aseptic Processes
  • Consent Decree Remediation
  • Inspection Readiness
  • Batch Disposition
  • Project Management
  • Safe Quality Food
  • Six Sigma
  • Document Control
  • Software Implementation
  • CFR 210/211/820/803/806/58/11
  • Team Training & Development
  • ISO 9000/13485/14001
  • Lean Management
  • Star LIMS Implementation
  • LIMS and DMS Implementations
  • Phase I-III Trials
  • Change Management
  • GAMP principles
  • UAT/Regression Testing
  • SAP Quality Management module
  • Quality Management Systems

Certification

  • Six Sigma Lean, Six Sigma Academy Amsterdam, 11/01/17
  • ISO/QS 9000 Quality System Auditing, ASQ, 01/01/00
  • Hazard Analysis Critical Control Point (HACCP), 2017
  • Introduction to PMP Principles, Cambridge Consulting, 08/01/07
  • Risk Management Integration, Simpli Learn, 2016
  • ICH (E6) R2 – Training, Pharm Intelligence, 12/01/18
  • ISO 14155-Training, Pharm Intelligence, 12/01/18
  • Root Cause Analysis for Continual Improvement / Supply Chain Risk Management, IFSQN
  • Introduction to Specialized Micro Processors, Star Technical Institute, 1991-1992
  • Project Management (PMP), SimpliLearn
  • Certified Quality Engineer, ASQ, 2015
  • Six Sigma Black Belt (Coursework), 11/01/17

Affiliations

  • Volunteer Fire Personnel
  • Film Editor
  • Community Projects

Accomplishments

  • Presidents Award for outstanding quality - 2009

Timeline

Global GMP Applications IT Portfolio Project Manager (Contractor)

Hikma Pharmaceuticals via Devfi systems
12.2024 - 05.2025

Senior Manager, Quality Systems (Consultant)

Sharp Packaging Solutions
09.2023 - 04.2024

Oxford Global International
03.2022 - 08.2023

Consulting Services Manager

Accenture North America
01.2020 - 05.2022

GCP, GMP Quality Systems Remediation Consultant

Recordati Rare Disease Group, North America
07.2019 - 10.2019

GMP Medical Device Quality Systems Implementation Director (Consultant)

HemaTechnologies (Formerly Air Scan Inc.)
02.2019 - 04.2023

FBS Master Control Implementation Project Manager

Tissue Tech Inc.
05.2018 - 12.2018

Senior Quality Professional/Manager/Director

CONSULTING SERVICES for Multiple Organizations
01.2011 - 04.2018

Compliance Specialist II

MedImmune, LLC
10.2004 - 10.2010

Quality Systems specialist II CMO program

Cambrex Bio Sciences
01.2004 - 10.2004

Quality Systems Specialist Bulk Liquid Manufacturing

Alpharma USPD
12.2002 - 11.2003

ISO 9001 Automotive Supplier Quality Engineer

East Penn Manufacturing
05.2000 - 07.2002

ISO/QS 9000 Automotive Quality Engineer

Chicago Rawhide SKF
03.1998 - 04.2000

Finished Product Quality Assurance

John Harland Check Printing
07.1995 - 02.1998

Bachelor of Sciences - Business Administration/Sciences - US

New York State University

Some College (No Degree) - Information Technology (IT)

University of Phoenix

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