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Click here or scroll down to respond to this candidateCONTACT:Homewood, ILEMAIL AVAILABLEPHONE NUMBER AVAILABLELINKEDIN LINK AVAILABLEsantoro-cssbb-tqmp-Street Address
SPECIALTIES:Quality Management System &ComplianceFDA GMP Medical Device &Pharmaceutical RegulationsEU MDR, Health CanadaSOR/98-282, Brazil ANVISA,Australia TGAHoshin Kanri / Strategic Planning& ImplementationDesign Assurance / ProductDevelopment / APQPBusiness Intelligence, KPI,Metrics, and AnalyticsKaizen / ContinuousImprovement / Six Sigma / 8DLean Principles & Tools (5S,Kanban, Error Proofing, VSM,OEE, TPM, Visual Factory)Software Development Life-Cycle(SDLC) GAMP5 & CSVEDUCATION-ACCREDITATIONSTQM Professional,Union of Japanese Scientists andEngineers (JUSE) YukihiroAndo consultingLean / Six Sigma Black Belt,SBTI Lean / Six Sigma ProgramBenedictine University,MBA coursework (GPA, 4.0)Joliet Junior College, AAS,IT System AdministrationNorthern Illinois UniversityBS, Biological SciencesMinor, ChemistryMEMBERSHIPS- CERTIFICATESSpecial Advisor to the DemingPrize Committee, JUSEAmerican Society of QualityComputer System ValidationSpecialistITIL v3 Foundations Certification(IT Management System)Certified CiceroneHapkido Black BeltRICHARD SANTOROEXECUTIVE DIRECTOR, LEADING QUALITY, COMPLIANCE, STRATEGY AND OPERATIONAL EXCELLENCESUMMARY:Passionate, customer-focused executive that combines expertise in Quality, Compliance, and Continuous Improvement to deliver solutions that meet the needs of customers, employees and the business. Progressively expanded my role and influence with exposure to both mature and early phase Quality Management System (QMS) implementations. Developed and mentored a management team able to cascade Quality Standards and Lean Principles through training services, internal consulting, and project management. Served as Quality System Representative engaging with FDA and 3rd-Party ISO 13485 certification bodies. Successfully closed an existing FDA Warning Letter through rigorous upgrade to the QMS and deep understanding of regulations.My career has taken me from the frontlines into consulting, and from business owner to company executive. Experienced in providing cross- functional leadership in a highly matrixed, global setting. This background 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 Total Quality Management(TQM), being named as Special Advisor to the Deming Prize Committee. Identified as High Potential employee at Baxter Healthcare, where I completed the Corporate Leadership program. Became company culture champion through direct training and certification by the GC Corporation owner and Chairman.EXPERIENCE:BOD CONSULTING LLCMarch 2024 currentProvide expert QMS and Operational Excellence consulting services for clients in the life science industries (Pharmaceutical, Medical Device, Biotech).EXECUTIVE DIRECTOR OF QUALITY MANAGEMENTGC America Inc. (Medical Device & Pharmaceutical)October 2012 March 2024Alsip, ILNorth & South American division of a Global $1B Medical Device Company in the Dental Materials industry. Led initiatives that netted the company millions of dollars in hard value, cost avoidance and compliance risk mitigation. Served as Interim Director of Manufacturing & Supply Chain on two occasions, providing leadership to successfully resolve quality issues, multi-million dollar back orders, and challenges in morale. Implemented an entirely new value stream, in compliance with FDA cGMP drug manufacturing regulations, which represents the companys largest revenue growth. Drove the global Quality strategy for the expansion of scope to the QMS for sterile manufacturing and distribution. Global Computer System Validation lead, accountable for system specifications, User Acceptance Testing (UAT) and compliance.Quality Assurance & Compliance Led the companywide QA Function, and Manufacturing / Supply Chain Function on an interim basis, driving full integration of global best practices to establish a world-class QMS: Led a multi-site team on the management of the QMS; Quality Audits, CAPA/Nonconformity, Supplier Quality, Design Assurance, Change Control, Document Management, Computer System Validation, Complaint management, and Quality data trending & analysis. Provided cross-functional leadership for the implementation of global packaging/labeling controls, Technical File delivery for EU MDR, site licensing and device listings for US FDA, Health Canada, and ANVISA. Drove expansion of scope for the QMS to align with global market strategy; achieved QMS certification to ISO 13485:2016 and MDSAP and for the inclusion of sterile implantable devices. Led the transformation of plant operations to establish an FDA Drug compliant manufacturing system, according to ISO 5 Cleanroom certification, enabling the expansion 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) and eQMS. Provide governance over Contract Manufacturing Organizations(CMOs) for the production and packaging of sterile, implantable devices in the bone grafting product category:o Develop and approve Quality Assurance Agreements with CMOs. o Provide QMS review and approval of process, test method, sterile barrier, and sterilization cycle validations.o Execute site audits of production, aseptic processing, sterilization cycles, packaging, clean room controls, and environmental monitoring for the CMO facilities. Established local Design Quality system for Design Assurance over new product development and design transfer into CMC operations. Business Excellence Received expanded functional ownership from Global Top Management, taking on the TQM function for the company, including Strategic Planning & Implementation and the Kaizen system. Built a team of interdisciplinary professionals that provide critical business services around process management, project management, data management and analytics. Own the Hoshin Kanri system for strategic planning & implementation, establishing KPIs / metrics based on global objectives and industry benchmarks. Manage progress of 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 performance on the kaizen / continuous improvement program, increasing employee engagement on problem-solving to a peak 98% participation, delivering over $2M in annualized value. Established the companys Project Management Office, enhancing timely execution of product launches, software implementation, and process change initiatives. Developed a highly proficient team to integrate business systems for the deployment of a business intelligence platform, providing improved data visualization, business analytics, and reporting. Established and sponsored the global roadmap for the implementation and validation of a comprehensive enterprise eQMS software solution. Quality Control Operations Further expanded scope of ownership, re- organizing and optimizing lab operations. Established cross-training and knowledge sharing for flexible daily management in the Quality Control (QC) lab. Achieved 12% efficiency increase on testing services. Enhanced test methods and QC Technician performance to assure the quality, safety and efficacy of new and existing products. Manage design transfer and scale-up to production, leading test method validation, process validation, and equipment qualification. QUALITY ASSURANCE MANAGERSears Holdings Corporation (Retail Merchandise)April 2012 October 2012Hoffman Estates, ILRecruited to lead the newly formed QA organization. QA was a new endeavor at 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 services and teamwork. Drove the integration of Information Security System controls into the daily management of the IT development team.QUALITY SYSTEM ENGINEERBaxter International Inc. (Medical Device)April 2009 April 2012Deerfield, ILCertified 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 and drove project initiatives. o Coached and mentored Six Sigma Green Belt trainees on the Process Excellence methodology and Lean tool usage. Owned and created Corporate Quality policies and procedures for the Design Quality systems and regulatory compliance strategies, assuring that products meet customer requirements. Provided project management service and QMS process management leadership for risk management and compliance strategies, aligning with regional and functional partners. Lead Investigator for problem-solving projects and CAPA, utilizing data analytics and Value Stream Mapping to drive improvements. Subject matter expert for internal and external audits. Hosted FDA and corporate auditors to mitigate risks on medical devices and enterprise eQMS software systems.QUALITY SYSTEM REPRESENTATIVEBaxter International Inc. (Medical Device)May 2006 April 2009Deerfield, ILKey project quality resource, consulting with cross-functional teams on system design and validation for the Electronic Home Care solution and enterprise eQMS 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, UAT 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 management, software design, CSV, and compliance. Trained and mentored new and contract resources on the product & software development systems, and compliance strategies. Provided operations support and change management approval for the management of quality standards.SOLE PROPRIETORMMA Productions (Sports business)February 1998 March 2007Crest Hill, ILEntrepreneur 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. 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. Professional Mixed Martial Arts Competitor, Sherdog Fighter Database.COMPUTER SYSTEM VALIDATION LEADApex Systems (Consulting @Baxter International, Medical Device) January 2006 May 2006Deerfield, IL 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 and education to additional company resources for validation master planning on integrated systems and shared services. Recruited into full-time direct hire role by the clients Director of Quality, based on performance and value to the company.VALIDATION & COMPLIANCE CONSULTANTComputer Task Group (Consulting @Schering-Plough, Medical Device) May 2003 May 2004Memphis, TN Completed a full system audit and gap assessment for the companys 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 Life-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.QUALITY CONTROL CHEMISTAmerican Pharmaceutical Partners (Pharmaceuticals) 1999 2003QUALITY CONTROL CHEMISTAlpharma (Animal Health)1997 1999QUALITY CONTROL ANALYSTYoh Scientific Inc (Consulting @Lipton Foods, Food Manufacturing) 1996 1997 |
