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Matthew Ostrowski
Director, Quality @BW Design Group
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WORK HISTORY
Director, Quality @BW Design Group
Boxborough, MA, US
Providing Quality Consulting services nationally for the life sciences market.
EDUCATION
University of Wisconsin-Madison
QCxP Certification, Building Commissioning
Binghamton University
BSME, Mechanical Engineering
Binghamton University
Bachelor of Science - BS, Mechanical Engineering
SKILLS
ABOUT MATTHEW OSTROWSKI
With 18+ years of proven expertise in pharmaceutical and biotechnology quality assurance and validation, I specialize in building world-class quality systems that drive operational excellence and regulatory compliance. As Principal Consultant and Director at BW Design Group, I help life sciences organizations navigate complex quality, validation, and technology transfer challenges while accelerating time-to-market.Key Achievements: Built and scaled high-performing QA teams from 1 to 15 members in under 2 years Delivered 100% compliance rates across 15+ technology transfers for Cell & Gene Therapy clients Drove 100% increase in CDMO revenue through strategic quality management Reduced digital system implementation timelines by 50% using innovative CSA methodologies Led successful remediation efforts under FDA consent decree with zero enforcement actions for in scope projects.Core Specializations:• Digital Systems (Veeva, Apprentice, SAP, LIMS, Digital CMMS, Trackwise, Syncade, Kneat) & Data Integrity Programs (Part 11 and Annex 11 Compliance)• Cell & Gene Therapy Manufacturing & Viral Vector Production• Technology Transfer & CDMO Management• Risk-Based Validation (ISPE GAMP) & Computer System Assurance• Regulatory Compliance (FDA, EU) & Inspection ReadinessCurrent Focus: Providing national quality consulting services for life sciences organizations seeking to optimize their quality systems and operations, implement digital transformation initiatives, and achieve sustainable compliance excellence.I\'m passionate about mentoring emerging quality professionals and staying at the forefront of industry innovation. Whether you\'re scaling manufacturing operations, implementing new digital systems, or preparing for regulatory inspections, I bring both strategic vision and hands-on expertise to drive results.Ready to elevate your quality systems and operations? Let\'s connect: m••••••••@bwdesigngroup.com
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