Also known as: markQbaldwin
Purpose-driven, analytical, and persevering QUALITY MANAGEMENT PERFORMANCE EXCELLENCE professional with a verifiable record of success in leadership roles of progressively greater responsibility at multi-national sciencetechnology based companies. Respectfully assertive, emotionally intelligent team leader and coach known for sound judgment and businessfinancial acumen, with hands-on experience leading technology implementation and process improvement programs under challenging conditions. Owing to a genuine and credible desire to help others succeed, able to engage diverse stakeholders at all levels in all functions, actively acquire an understanding of their needsconcerns, surface and resolve conflicts, build collaborative working relationships, and promote alignment with common goals in a matrix organization through effective negotiation. Areas of Expertise - Process Management (planning, definitiondesign, measurement, analysis, control, optimization, continual improvement, Lean, Six SIgma) - Quality Management Systems (ISO , ISO , FDA QSR, ICH Q) - Measurement Analysis (metrics, balanced scorecards, key performance indicators KPI, dashboards, data quality management, application of statistical methods to transform data into knowledge and communicate meaning effectively) - Risk Management (QRM, ICH Q, ISO ) - Project Management (portfoliodemand management, project initiation, planning, execution, control, closeout PMI management of scope, time, cost, quality, risk, resources, stakeholder communications and expectations) - Fact-Based Problem Solving using structured methods - Information Systems optimization If you're not improving, you're falling behind. The only sustainable advantage is the ability to learn and improve at a faster rate than your competitors. Certified Manager of Quality and Organizational Excellence (ASQ CMQOE). CONTACT .. Specialties Process Management (Lean, Six Sigma, OpEx, DMAIC, SPC, PDCA, VSM, COQ) Performance Measurement Analytics (metrics, KPI, scorecard, dashboard) Compliance auditing risk-based tailoring of quality plans controls Risk Management Process Mapping, Data Modeling (VSM, SIPOC, BPMN, multi-D OLAP, UML, ERD) ITSoftware Process (SDLC, CSV, GAMP , ITIL, ISO, PMI, CMMI, ERP, SAP, BI) Pharmaceutical regulations (ICH, FDA CFR, GLP, GMP, QSR, QbD, validation)
