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Daniel Whalen Location
Lake Villa, IL, US
Daniel Whalen Work
now Self-employed
2024 -now Principle Consultant Quality Systems and Assurance
2021 -2024 Director Of Quality @
2020 -2021 Senior Quality Manager @
2017 -2020 Manager Quality Assurance @
2015 -2017 Quality Manager II Global Technical Services @
2010 -2015 Supplier Quality Manager @
2006 -2010 Quality Manager @
2004 -2006 Quality Analyst - Process Developement @
2004 -2006 Quality Analyst - Process Developement @
1998 -2004 Business Learning Consultant @
1998 -2004 Business Learning Consultant @
1990 -1994 Captain @
1990 -1994 Captain @
Daniel Whalen Education
Marquette University
Bachelor of Arts (History)
1986-1990
Daniel Whalen Skills
Industry standards
Analytics
Operations
Product Testing
ELISA
OOS
Pre-approval
Manuals
U.S. Food and Drug Administration (FDA)
Software Development Life Cycle (SDLC)
Project Management
Health Canada
Australia TGA
Quality Process Development
FDA GMP
Resource Allocation
Program Planning
Sterile Processing
Biologics
Site Inspections
Observation
Marketing
Code of Federal Regulations
Strategy
Oral Communication
Contractual Agreements
Pivot Tables
Batch Records
Attention to Detail
Test Processes
Data-driven Decision Making
Automotive
Facilitation
Lean Processes
Coaching
Financial Performance
Third-Party Logistics (3PL)
Retention Strategies
Employee Engagement
Customer Requirements
Team Management
Management
Defining Requirements
Cross-functional Team Leadership
Group Leadership
Biotechnology
Forecasting
Key Performance Indicators
Multi-country
Key Metrics
Standard Operating Procedure (SOP)
ISO 13485
ICH
Document Management
CAPAs
Analytical Skills
Regulatory Submissions
Regulatory Guidelines
GxP
Problem Solving
Good Manufacturing Practice (GMP)
Manufacturing Process Improvement
Business Process Improvement
Good Laboratory Practice (GLP)
Interpersonal Skills
Research and Development (R&D)
Regulatory Requirements
Vendor Audit
Strategic Leadership
Communication
Capital Expenditures
Purchase Recommendations
Pharmaceuticals
Quality Assurance
Director level
Quality Management
Certified Quality Auditor ASQ-CQA
Six Sigma
APQP
Product Development
Program Management
Quality System
Continuous Improvement
DMAIC
Testing
CQA
Engineering
Supplier Quality
ISO
SPC
FMEA
Quality Auditing
CAPA
Advanced Product Quality Planning (APQP)
Failure Mode and Effects Analysis (FMEA)
ISO Standards
Certified Quality
Advanced Product Quality Planning Apqp
Certified Quality Auditor Asq Cqa
Failure Mode and Effects Analysis Fmea
Advanced Product Quality Planning
Failure Mode and Effects Analysis
Daniel Whalen Summary
Daniel Whalen brings experience from previous roles at Self-employed, Hugel Aesthetics, Novartis and Merz North America. Daniel Whalen holds a 1986 - 1990 Bachelor of Arts in History @ Marquette University. With a robust skill set that includes Industry standards, Analytics, Operations, Product Testing, ELISA and more.
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