Richard Santoro, Cssbb, Tqmp Email and Phone Number

Provide expert Quality Management System and Operational Excellence consulting services in the life science industries (Pharmaceutical, Medical Device, Biotech).

Quality Assurance & Compliance:• Lead multi-site team on the management of the QMS; Quality Audits, CAPA, Supplier Quality, Design Assurance, Change & Document Control, Computer System Validation, and Complaint Management.• Drove QMS scope expansion; achieved QMS certification to ISO 13485:2016 and MDSAP.• Led the establishment of an FDA Drug compliant manufacturing system, expanding the scope of the preventive care portfolio.• Led the system design, UAT and post-go-live hyper-care phases for the site implementation of a global ERP system (SAP).• Lead Design Assurance for new product development, establishing production lines, quality checks, and preventive controls.Business Excellence:• Own the Hoshin Kanri system, establishing KPIs based on global objectives and industry benchmarks. Manage action plans and KPI achievement with business unit heads.• Drive company-wide implementation of TQM & Lean Tools, including 5S, VSM, Kanban, Error Proofing, Visual Management, and SPC.• Enhanced kaizen program performance, increasing engagement to a peak 98% participation, delivering over $2M in annualized value.• Established a Project Management Office, enhancing timely execution of product launches, software implementation, and change initiatives. • Developed a highly proficient team to integrate the company’s business systems, for the deployment of a business intelligence platform, providing improved data visualization and analytics.• Leading the global roadmap for the implementation and validation of a comprehensive QMS software solution. Quality Control:• Established cross-training system for knowledge sharing and flexible daily management standards. Achieved 12% increase in efficiency on testing services.• Enhanced test methods and QC Technician performance to assure product quality, safety and efficacy for new products.• Manage design transfer and scale-up to production, leading test method validation, process validation, and equipment qualification.

Recruited to lead the newly formed QA organization. QA was new element of Sears Holdings operations, so it was a ground floor opportunity. • Performed process engineering for the corporate IT infrastructure teams on the development of quality processes. Collaborated to create and implement IT Service Management procedures for Event Management, Change Management, and Incident Management.• Received executive recognition for excellence in internal service and teamwork.• Drove the integration of Information Security System controls into the daily management of the IT development team.

Certified Lean / Six Sigma Black Belt – Implemented process improvements providing over $1M in annual cost avoidance and over $3M in annual risk mitigation:• Program Manager for Continuous Improvement in the Quality Compliance organization: o Chaired the Process Excellence Steering Committee.o Managed internal metrics to drive improvement initiatives.o Coached and mentored Six Sigma Green Belt trainees on the Process Excellence methodology and Lean tool usage.• Provided project management and QMS process leadership for risk management and compliance strategies. Included Business, Regional and Functional partners across the company.• Identified as “High Potential” employee, nominated into and completed the Baxter Leadership program.• Owned and created Corporate Quality standards for Design Quality systems and regulatory compliance strategies.• Lead Investigator for quality improvement projects, utilizing data analytics and VSM to drive process optimization.• Subject matter expert for internal and external audits, managed relations with FDA and corporate auditors to mitigate risks on medical devices and enterprise QA software systems.

Key project quality 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 for review and approvals on validation deliverables, with full responsibility for compliance.• Serve as SME for development and execution of unit & integration testing, as well as, User Acceptance Testing during CSV projects.• Performed medical device and procedure audits to drive system optimization, implementation of risk controls, and 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 process & computer system validation, and compliance.• Trained and mentored new and contract resources on the company development systems and compliance strategies.• Provided operations support and change management approval for the management of quality standards.

Entrepreneur in sports production; producing live prize fighting events, providing international & state sanctioning, licensing merchandise, and managing media content in video, print and online forms:• Event Producer – Stage Manager, Event Coordinator, Travel / Hotel accommodations, Audio-Visual Specialist• Video Production Lead – Audio-Visual Contracts, iNDEMAND Pay-Per View negotiations, DVD distribution• International Competition Organizer – ADCC Submission Wrestling World Championships rules meetings, weigh-ins, event logistics, production coordinator• International SHOOTO Commission, North America – Event sanctions, judging, certify officials, coordinate approval of matchups & weigh-ins, deployed U.S. rules & regulations in cooperation with State Athletic Commissions, including NV, FL, IL, TN, NY, MO, and the Association of Boxing Commissions, trademark holder in US.• Matchmaker – Licensed by Nevada State Athletic Commission• TV / DVD Color Commentator – Chicago SportsNet broadcast• Fightworld Video Magazine – Ringside / Backstage Interviewer• MaXfighting.com content editor and contributor• Freelance Mixed Martial Arts journalist – Contributor to Grappling Magazine, FCFighter.com, Sherdog.com, Fightworld.com• Semi-Professional Mixed Martial Arts Competitor

• Developed and managed the validation strategy for the deployment of a category 5 custom-built medical device application.• Produced all validation deliverables, including quality standards in compliance with the corporate QMS and validation processes.• Provided cross-functional expertise for training to additional company resources on validation master planning and quality standards.• Recruited into full-time direct hire role by the clients Director of Quality, based on performance and value to the company.

• • Completed a full system audit and gap assessment for the company’s legacy Data Acquisition System.• Developed and executed computer system validation strategy, achieving system optimization and compliance.• Collaborated with subject matter experts and the user base to optimize System Development Lide-Cycle and usage procedures.• Produced and implemented the 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.