Scott Mehltretter
Director, Global Compliance and Supply Chain Quality
- Role
- Director, Gmp Compliance at Lonza
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Scott Mehltretter
Data-driven Biopharmaceuticals Manager with over 25 years progressive industry experience in Quality Assurance, Bioprocess Manufacturing and Development. Significant experience with implementation of Quality Systems in a Contract Manufacturing business model. Strong skills in audit of cGMP manufacturing and GMP suppliers, compliance with global regulatory requirements and Quality Systems development. Skilled problem-solver and experienced leader of global cross-functional teams. Specialties: Quality Systems, FDA & ICH Compliance, Supplier Audit, Internal/External Audit, Inspection Management, Change Management, Contract Manufacturing, Validation – Process, Analytical Method, Equipment, IT Systems, TrackWise
Experience
Director, Gmp Compliance
Oct 2021 — Present · Raleigh-Durham-Chapel Hill, NC, US
Responsible to develop, plan and execute a program of corporate GMP compliance audits/assessments for Lonza’s manufacturing sites, including solid dosage forms, cell/gene therapy (sterile dosage forms), bulk biological and chemical APIs and Drug Products, medical devices and excipients. Advise, guide and lead support for sites in the preparation for, and overall management of, regulatory inspections. Follow-on action to support site responses to findings and develop remediation plans as required. Provide expertise to sites and the global organization on all aspects of GMP compliance and best practices, including sterility assurance, as well as new and developing GMP regulatory requirements and trends and data integrity.Ensure the uninterrupted supply of materials and services to Lonza within area of responsibility by assessing the quality of the Suppliers and their ability to meet defined requirements utilizing tools such as Quality Risk Management (QRM), supplier assessment/audit, change management, and complaint/deviation trend management. Support continuous improvement initiatives of Global Quality systems related to regulatory compliance for cGMP and industry best practices.
Education
University of Virginia
BS, Engineering Science
1984 — 1988
San Diego State University
Certificate, Regulatory Affairs
2006 — 2007
Northeastern University
MS, Regulatory Affairs
2007 — 2009
Skills
- Bioprocessing
- Vendor Management
- Capa
- Fmea
- Change Management
- Fda
- Validation
- Sterilization
- Pharmaceutical Manufacturing
- Quality System
- Document Management
- Quality Management
- Cell Culture
- Quality Auditing
- Aseptic Processing
- Cgmp Manufacturing
- Change Control
- Gmp
- Technology Transfer
- Process Optimization
- Compliance
- Trackwise
- Contract Manufacturing
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