CONTACT:

Homewood, IL

adiq6l@r.postjobfree.com

815-***-****

www.linkedin.com/in/richard-

santoro-cssbb-tqmp-234659

SPECIALTIES:

Quality Management Systems

Design Quality / APQP / Product

Development & Process Validation

Hoshin Kanri / Strategic Planning

& Implementation

Kaizen / Continuous Improvement

Lean Operations / Six Sigma

Leadership & Mentoring

Technical & Creative writing

Regulatory Affairs & Compliance

• 21 CFR Part 820

• 21 CFR Part 210/211

• 21 CFR Part 11

• ISO 13485:2016 – MDSAP

• CMDR SOR/98-282

• NHP SOR/2003-196

• EU MDR / MDD

EDUCATION-CERTIFICATIONS

TQM Professional,

Union of Japanese Scientists and

Engineers (JUSE) – Yukihiro Ando

consulting

Lean / Six Sigma Black Belt,

Baxter Corporation – SBTI Lean /

Six Sigma Program

Benedictine University,

MBA coursework (GPA, 4.0)

Northern Illinois University

(1991 - 1996),

BS, Biological Sciences

Minor, Chemistry

ITIL v3 Foundations Certification

(IT Management System)

Project Management Body of

Knowledge (PMBOK)

MEMBERSHIPS-HONORS

Special Advisor to the Deming

Prize Committee, JUSE

GC Corporate Culture Champion

Baxter Leadership Program

American Society of Quality

School Board President, IL-88

Cicerone Certification

Hapkido Black Belt

RICHARD SANTORO

EXECUTIVE LEADER OF QUALITY, STRATEGY AND CULTURE

SUMMARY:

I am a passionate, people-oriented executive that combines a multi- disciplinary background in Quality, Compliance, Science, Strategy, Continuous Improvement and Entrepreneurialism to deliver solutions that meet the needs of the customers, employees and the business. Progressively expanded my role and sphere of influence with exposure to both mature Quality Management Systems (QMS) and early phase implementations. Developed and mentored a team of quality & compliance professionals, able to cascade Quality Standards and Lean Principles throughout the company using multi-tiered training methods, internal consulting and cross-functional project management. My career has taken me from consulting, to individual contributor, up to the executive level in Quality Management, reporting to a C-level executive. I now lead multiple departments and cross-functional teams in a highly matrixed, global setting. This experience, along with owning my own business has taught me the importance of ownership, execution and communication. I have leveraged this background to establish an award winning QMS, receiving the Deming Prize for Excellence in TQM, where I was named a Special Advisor to the Deming Prize Committee. EXPERIENCE:

EXECUTIVE DIRECTOR OF QUALITY MANAGEMENT

GC America Inc., Alsip, IL (Medical Device, OTC Drug) October 2012 – Present

GC America (GCA) is the North & South American operation for GC Corporation (GCC) headquartered in Japan. GCC is a $1B company world-wide, which designs, develops, manufactures and distributes Medical Devices, Pharmaceuticals, and Combination Drug/Devices used by Dental Professionals. As a member of the Executive Committee, I report directly to the President & COO, collaborating with business partners to set strategy, drive Quality Management System enhancements, and assure GxP compliance.

Quality Assurance & Compliance – Lead the companywide QA Function, driving full integration of GxP regulatory requirements and global best practices, establishing a world-class QMS:

• Own the deployment of the QMS; Quality Audits, Design Quality, Document Control, CAPA, Change Control, Supplier Quality, Adverse Events, Advisory Notices, and Management Review.

• Provide cross-functional leadership to Manufacturing, Marketing, Engineering, Supply Chain and R&D to align with the global compliance strategy, thereby enabling the business to attain multi- national sales & distribution targets:

o Drove the expansion of scope of the QMS, achieving ISO 13485:2016 certification, as well as, certification from Health Canada for the Medical Device Single-Audit Program (MDSAP). o Led the transformation of plant operations to establish an FDA Drug compliant manufacturing system. This paved the way for the expansion of the preventive care product portfolio. o Managed the successful closure of an inherited FDA Warning Letter for misbranded products.

• Developed standards for Quality and Supplier Agreements and certify 3rd-parties for sourcing of raw materials and services.

• Serve as regulatory representative, reviewing all product development milestones and approve product registration dossiers.

• System owner for the global document management system

(MasterControl). Sponsored and completed the expansion of scope to deploy the full eQMS suite, Training module and Product Registration functionality on a world-wide scale.

• Specially trained by the company chairman to champion the dissemination of company culture, as a GC no Kokoro Storyteller. Business Excellence – Expanded functional ownership, taking responsibility for the company-wide Strategic Planning & Implementation and Continuous Improvement systems:

• Built a team of interdisciplinary professionals that provide critical business services around process management, project management, data analytics, and business reporting.

• Own the Hoshin Kanri system for strategic & tactical planning, collaborating with business function owners to established KPIs and targets based on global strategy and industry benchmarks.

• Chair the Hoshin Kanri functional review; managing progress on action plans and KPI achievement.

• Drive the company-wide implementation of TQM & Lean Tools, such as 5S, VSM, Kanban, Error Proofing, Visual Management, and SPC.

• Enhanced education program for Kaizen / continuous improvement, increasing employee engagement on problem-solving with a 98% participation level, delivering over $3M in annualized value.

• Established the company’s Project Management Office, managing high priority, complex projects; including product launches, software implementation, and change management initiatives.

• Integrated company business systems to deploy a business intelligence framework that improves data visualization and analytics. Key systems delivered include the EBD management system, nonconformity database, and capital expense system. Quality Control (QC) Operations – Further expanded leadership position and ownership by taking on the distressed QC department:

• Re-organized the QC department through a personalized talent development and recruitment strategy.

• Established learning management structure to ensure knowledge sharing and exchange. Achieved a 12% increase in the delivery of testing services for finished goods and incoming raw materials.

• Enhanced QC capabilities, reducing the Cost of Quality by more than $130k annually, through an increase in first-time pass results.

• Improved the existing 5S audit program reducing processing errors and defects by 8% in the 1st year.

QUALITY ASSURANCE MANAGER

Sears Holdings Corporation, Hoffman Estates, IL (Retail Merchandise) April 2012 – October 2012

Recruited to lead the newly formed QA organization.

• Coached the corporate IT infrastructure teams on the development of quality processes; including implementation of IT Service Management procedures for Event Management, Change Management, and Incident Management.

• Received executive recognition for excellence in internal service.

• Drove the integration of Information Security Systems into the daily management processes of the IT development team.

QUALITY SYSTEM ENGINEER

Baxter International Inc., Deerfield, IL (Medical Device) April 2009 – April 2012

Certified Lean / Six Sigma Black Belt – Implemented process improvements providing over $1M in annual cost avoidance and over

$3M in annual compliance risk mitigation.

• Program Manager for Continuous Improvement in the Quality Compliance organization:

o Chaired the Process Excellence Steering Committee. o Managed internal metrics and drove project initiatives. o Coached and mentored Six Sigma Green Belt trainees on the company’s Process Excellence methodology.

• Provided project and QMS process management leadership for risk management and compliance activities. Served as subject matter expert for risk management and design, meeting with FDA in regard to a consent decree.

• Identified as High Potential employee; completed the Baxter Leadership program.

• Owned creation of Quality policies and procedures for Design Quality systems, assuring product quality and regulatory compliance.

• Lead Investigator for CAPA projects related to medical devices that are integrated with IT systems and imbedded software.

• Subject matter expert for internal and external audits, reporting on medical devices and enterprise QA software systems. QUALITY SYSTEM REPRESENTATIVE

Baxter International Inc., Deerfield, IL (Medical Device) May 2006 – April 2009

Key compliance resource, consulting with cross-functional teams on system design and validation for the Electronic Home Care solution and enterprise QA software systems:

• Partnered with design & development teams to develop and approve validation deliverables, with full responsibility for compliance.

• Performed medical device and procedure audits to drive system optimization, implement risk controls, and assure compliance.

• Quality System Representative for FDA audits, mitigating existing nonconformities and preventing occurrences of new findings.

• Participated in Community of Practice resource groups, promoting best practices for system development and regulatory compliance.

• Trained and mentored new and contract resources on the company product development systems and overall QMS.

• Provided operations support and change management approval throughout the product life cycle.

COMPUTER SYSTEM VALIDATION LEAD

Apex Systems (Consulting, Medical Device)

January 2006 – May 2006

• Developed and managed the validation strategy for the deployment of a category 5 custom-built medical device application.

• Managed the production of all validation deliverables in compliance with the corporate QMS and computer system validation processes.

• Provided cross-functional expertise for training and education to additional company resources for validation master planning on integrated systems and shared services.

SOLE PROPRIETOR

MMA Productions (Sports business)

February 1998 – March 2007

Entrepreneur producing live prize fighting events, providing international

& state sanctioning, licensed merchandise, and managed media content in video, print and online forms. SHOOTO trademark holder in US.

• International SHOOTO Commission, North America – Event sanctions, judging, certify officials, coordinate approval of matchups

& weigh-ins, deployed U.S. rules & regulations aligning with NV, FL, IL, TN, NY, MO, and the Association of Boxing Commissions,

• Semi-Professional Mixed Martial Arts Competitor

• Matchmaker – Licensed by Nevada State Athletic Commission

• Event Producer – Stage Manager, Event Coordinator, Travel / Hotel, Audio-Visual Specialist

• TV / DVD Color Commentator – Chicago SportsNet broadcast

• Fightworld Video Magazine – Ringside / Backstage Interviewer

• International Competition Organizer – ADCC Submission Wrestling World Championships rules meetings, weigh-ins, event logistics

• Video Production Lead – Event Audio-Visual Contracts, iNDEMAND Pay-Per View negotiations, DVD distribution

• MaXfighting.com content editor and contributor

• Freelance Mixed Martial Arts journalist – Articles published in Grappling Magazine, FCFighter.com, Sherdog.com, Fightworld.com VALIDATION & COMPLIANCE CONSULTANT

Computer Task Group (Consulting, Medical Device)

May 2003 – May 2004

• Completed full system audit and gap assessment for the company’s legacy Data Acquisition System.

• Developed remediation plan and executed validation strategy, achieving system optimization and compliance.

• Collaborated with subject matter experts and the user-base to create system use procedures.

• Produced and implemented a remediation plan for the broader QMS to assure compliance with FDA regulations and reduce risks.

• Provided weekly status and reports to the Corporate Compliance & Validation Review Board.

QUALITY CONTROL CHEMIST

American Pharmaceutical Partners (Pharmaceuticals) 1999 – 2003

QUALITY CONTROL CHEMIST

Alpharma (Animal Health)

1997 – 1999

QUALITY CONTROL ANALYST

Yoh Scientific Inc (Consulting, Food Manufacturing) 1996 – 1997

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