2016 -2018 President and Senior Quality Consultant @ DL QUALITY CONSULTING SERVICES
2015 -2016 Multi-Site Director of Quality Assurance and Regulatory Compliance @
2012 -2015 Director Quality and Regulatory Affairs @
2005 -2012 Corporate Quality Program Manager @
2002 -2005 Associate Director of Quality @
2001 -2002 Validation Manager @
1988 -2000 Quality Manager @
David Lino Education
Questrom School of Business, Boston University
Master of Business Administration (M.B.A.) (Business Administration and Management, General)
1995-1998
Bridgewater State University
BS (Biology & Chemistry)
David Lino Skills
Inspection Readiness
USP
GMP
Biotechnology
Quality Assurance
FDA
PMP
Cross Functional Team Leadership
GxP
Regulatory Submissions
Auditing
Risk Management
21 CFR Part 11
ISO 13485
Regulatory Requirements
MS Project
Quality System
Quality Auditing
Quality Management
Medical Device Directive
cGMP practices
Negotiation
Strategic Planning
CQA
Medical Devices
ICH guidelines
Leadership
Regulatory
Continuous Improvement
Compliance Remediation
Sales
Site Inspections
Root Cause Analysis
ISO
Regulatory Affairs
Process Improvement
Design Control
Strategy
Regulatory Compliance
KPI Dashboards
Data Validation
Compliance
Quality Control
Aseptic Processing
V&V
Audit Management
Multi Site Responsibility
DMAIC
Sop
Technical Files
Project Management
CAPA
Microsoft Office
Change Control
Validation
Marketing
Engineering
21 CFR
Pharmaceutical Industry
ISO 14971
Customer Service
Microsoft Excel
Public Speaking
David Lino Summary
David Lino, based in Boston, MA, US, is currently a Sr. Director of Technical Operations at SQ Innovation, Inc.. David Lino brings experience from previous roles at SEQENS, axogen, Avista Pharma Solutions and DL QUALITY CONSULTING SERVICES. David Lino holds a 1995 - 1998 Master of Business Administration (M.B.A.) in Business Administration and Management, General @ Questrom School of Business, Boston University. With a robust skill set that includes Inspection Readiness, USP, GMP, Biotechnology, Quality Assurance and more. David Lino has 4 emails and 2 mobile phone numbers on RocketReach.
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