Management Quality

GARY UTRUP

**** ******** **. **********, ** ***** Phone: 972-***-****

linkedin.com/in/garyutrup Email: ac0u4y@r.postjobfree.com

Accomplished, certified (CMQ/OE), and acknowledged goal-oriented leader with a comprehensive background in process management, suppler development, regulatory compliance; audits/assessments preparation, and facilitation for various quality management systems. Extensive multi-industry experience within R&D, Operations, Customer Support, Technical Service, Field Service, Laboratory Operations, 24/7 Manufacturing and Supplier Development processes and functions. Utilizing strong leadership and management skills; along with proven expertise in training and staff development and strategic planning to enhance the overall business profile. Experienced in Quality Management Systems development, deployment, remediation, auditing and assessing against FDA 21CFR, 211, 820, ISO13485, ISO 9001, AS9100, CLIA/CAP, Food Safety, MBNQP and AS requirements using excellent interpersonal skills, with proficiency in cultivating professional relationships and implementing best practices to develop highly effective business programs.

Areas of Expertise

Quality Management Systems

Regulatory Compliance

Customer Satisfaction

Process development/improvement

Complaint Handling

Management Change

Strategic planning/analysis

Project/process management

Risk Management / HACCP

Supplier Partnership Development

Team Leadership & Coaching

Training & Skill Development

EDGE process utilization

Auditing & Assessment

Process Management

Professional Experience

AMCOR RIGID PLASTICS USA, LLC, Ft. Worth, TX 2015 – Present

Pharmaceutical Compliance Manager

Corporate level position assigned to Ft. Worth plant; providing direction, strategic and tactical leadership, staff mentoring, training and onsite Quality Assurance/Control to the Diversified Products Pharmaceutical Business on the development and implementation of their FDA / ISO 9001/ ISO 13485/IFS PACSecure Food Safety Quality Management System, policies, procedures, processes, work instructions and records.

Specific Achievements:

Directed the strategic and tactical preparations, and assessment facilitation resulting in ISO 9001 and ISO 13485 QMS certification for multiple sites :

oFt. Worth, TX facility, the FIRST Amcor facility certified to ISO 9001 and ISO13485 [Dec. 2015].

oMillville, NJ facility [Apr. 2016], and Youngsville, NC facility [Jun. 2016], and

oBlythewood, SC [Apr 2017] and Itasca, IL [May 2017].

FDA QSIT Level II inspection with NO FDA483 issued [Jan. 2016].

Attained IFS PACSecure certification with a score of 99.9/100, highest score within Amcor Rigid Plastics USA.

KEN BLOCK CONSULTING, Richardson, TX 2009 – 2010, 2014 - 2015

Senior Quality Assurance/Regulatory Compliance Consultant

Providing strategic and tactical leadership, guidance, mentoring and onsite project management to various International Medical Device manufacturers on the development and implementation of their FDA/ISO Quality Management Systems policies, processes, procedures and records.

Specific Achievements:

Remediated Corporate and/or Site level design control, complaint handling process, adverse event reporting, supplier management, blood borne pathogen training, document control/records, executive management review, CAPA MDR reporting and analysis of data processes and systems. All clients had successful FDA re-inspections.

AXEON, Salt Lake City, UT 2014 - 2015

Quality Assurance/Regulatory Compliance Consultant

Conducting gap analysis and/or audits; identifying serious “gaps” or “holes” in a Quality/Business system, comparing actual work practices to international standard such as ISO 9001, AS9100, ISO 14971, and ISO 13485, Risk Management and FDA 21 CFR regulations.

Working with the client senior leadership and management to change a gap into strength, training on ISO/FDA, corrective action-preventive action and risk management with a focus on Class II and II devices.

MED FUSION LLC, Lewisville, TX 2010 – 2014

Senior QA Manager, QA/BI Analytics, Compliance & Process Engineering

Provided key strategic and tactical leadership, direction, guidance and onsite support to a new business venture in the esoteric diagnostic laboratory healthcare environment.

Specific Achievements:

Directed the developed and deployed a CAP/CLIA compliant Quality Management System; validation and implementation of MasterControl QES, an Opportunity for Improvement (Complaints/CAPA) process, adverse event reporting and analysis of data processes and systems engineering. Resulting in no observations or findings saving >$100M in remediation costs.

Defined, developed and deployed MasterControl, an FDA 21CFR, Part 11 compliant document and process control system for use in a CAP laboratory environment. Paperless documentation, saving >$100M/year.

ABBOTT LABORATORIES, Irving, TX 2000 – 2009

Senior QA Project Manager, QA Global Commercial Operations

Provided strategic and tactical leadership, direction, guidance, training, and support to the Global Service organization, building a profitable business environment compliant with ISO and FDA 21 CFR Quality System requirements.

Ensured alignment of global service organization with Division QMS remediation and refinement projects.

Established, implemented, maintained and monitored the Installation and Servicing policy, process and procedural family of documents for the Abbott Diagnostics Division.

Specific Achievements:

Directed the establishment and deployment of a robust Quality Management System for the US Commercial Operations Field Repair Center; including operational procedures, processes and metrics utilizing LEAN and simple processes; generated $1.1MM revenue annually and received an ADD CSO Management Award.

Engineered and deployed a Return Material Authorization (RMA) process between the US Commercial Organization and Dallas Manufacturing Operations that resulted in a saving of $376M in shipping costs annually, which is now web-based; was awarded an Abbott Vice President’s Award.

Established and implemented a 21CFR Part 806, Corrections and Removal review process for all engineering change notices (ECN); was awarded a WWCS General Managers Award.

ABBOTT LABORATORIES, Irving, TX

Site Manager, ADD-Dallas ISO/GMP Regulatory Compliance 1993 – 2000

Established, maintained and managed the ADD-Dallas Site ISO/EN/GMP Regulatory and Compliance environment and team.

Specific Achievements:

Lead site-wide project to upgrade ISO9001 certification to include ISO13485. Prepared the site, managed and facilitated all ADD-Dallas ISO, (9001 & 13485), TickIT & EN with no nonconformities for 9-years.

Developed and implemented an ISO/FDA Quality System Fair, which trained over 1,200 employees at a cost < $12.00/student, and a GMP retraining equivalency option for “required” annual refresher requirement saving 4-hours per employee per year. Awarded an Abbott Vice President’s Award.

Prepared Toshiba for first FDA inspection. Toshiba received zero FDA483s. Awarded an ADD President’s Award.

ABBOTT LABORATORIES, Irving, TX

Supervisor, Diagnostic Products Customer Technical Support & Training 1987 – 1993

Education & Training

SBB Master’s Program, Immunohematology for Medical Technologist, BB (ASCP), Bowling Green State University, Bowling Green, OH

Master’s Degree Program, Quality Control, Kennedy Western University, Cheyenne, WY

Bachelor of Arts, Biology, University Of Toledo, Toledo, OH

Training: Lead Assessor for ISO 9001; ISO 13485 and AS9100

Certifications & Skills

Certified Manager of Quality & Organization Excellence, ASQ

ISO 13485:2016, the Medical Device Single Audit Program and Regulatory Transitions, NSF-Medical Device

AS9100 Lead Auditor Exemplar Global (RABQSA) Certified (#Q19701), Exemplar Global

ISO 9001:2015 Transition Course Trainer, Axeon

ISO 31000, ISO 31010 & ISO 14971 Quality Risk Management, Axeon

Corrective Action & Root Cause Analysis Training, Axeon

ISO 13485, Association for the Advancement Medical Instrumentation [AAMI] & ASQ

ISO 9000 Lead Auditor (Assessor) Certified Training, (#L-3740), STAT-A-MATIX, Inc.

Food Safety/HACCP/Internal Auditing/Food Defense, AIB International

GMP Requirements and Industry Practice, AAMI & Food and Drug Administration [FDA]

Device Servicing/Refurbishment Rule, AAMI/FDA

Quality System Inspection Techniques [QSIT], FDA

Design Control, AAMI, FDA Medical Device Industry Coalition

Risk Management through Product Life Cycle, FDA Medical Device Industry Coalition

Integrating Risk Management into the Quality System, AAMI

Malcolm Baldrige National Quality Program Criteria, NIST & Quality Texas Foundation

Hazard Analysis and Critical Control Points, USFDA Medical Devices, Association of Food & Drug Officials

Leadership in 21st Century (Woodbadge), BSA The Trainers EDGE, BSA

Human Error Reduction, TALSICO, Inc. Picture Process Mapping, TALSICO, Inc.

Professional Affiliations

Texas Award for Performance Excellence (TAPE), Quality Texas Foundation

American Society for Quality, Senior Member

Boy Scouts of America, Longhorn Council, Tonkawa District

(District Commissioner, District Training Commissioner, Cubmaster, Assistant Scoutmaster, Unit Committee Chairman, and

Father of an Eagle Scout and mentor to 14 Eagle Scouts)

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