1. Mike Neidig, MBA
143 Dover Ave., La Grange, IL 60525 Cell: (630) 835-8117 email: mikejneidig@yahoo.com
Global Quality Assurance Director
Senior-level leader with proven track record and end-to-end experience driving pharmaceutical process development,
manufacturing and regulatory compliance requirements
Summary:
Accomplished QA professional with 15+ years of cross-functional pharmaceutical quality and manufacturing experience.
Established agent of change fostering a collaborative team environment to successfully drive significant business
objectives in quality-systems management, operations management, life-cycle management, personnel development,
supply chain management and planning. Patient and customer focused leader with proven ability to develop compelling
strategies that drive compliance and profitability.
Areas of Expertise:
 Quality Assurance Management
 Operations Management
 Sales and Operations Planning Management
 Corrective Action / Preventative Action
 Written and Oral Communication
 Six Sigma (DMAIC) Process
 Facilitation of Continuous Improvement
 Strategic and Tactical Implementation
 Scorecard Development and Tracking
 Standard Operating Procedure Creation
 Quality Assurance of Supply
 Regulatory Compliance (GMP/GLP)
 Regulatory Interface (Domestic and Foreign)
 New Product Development
 Validation
 Supplier Quality Assurance
 API, Solid Dose and Aseptic Manufacturing
 Pharmaceutical Packaging
 Enterprise Resource Management
 Materials Requirements Planning
 Risk Assessment (FMEA)
 Mastery of Presentation Skills
 Customer Service
 Software Use and Deployment (MS, SAP, INFOR)
Key Career Highlights:
 Quality by Design Process for Legacy Products – Develop corporate procedure to identify and mitigate product
portfolio vulnerabilities using Risk Assessment, Knowledge Management and Statistical Analysis (Cpk/Ppk).
 Remediation of Product Release and Stability Test Methods – Drive project to completion resulting in closure of
over 8,000 gaps as part of FDA commitment. Saved $4 million against planned budget of $24 million.
 Planning Excellence – Site Master Scheduler for packaging site supporting $9 billion in annual sales driving
strategic planning to elevate Customer Service to historic high of >99% and 0 backorders over 12 month period.
 Abbvie Name Change Project – Leader of production planning /conversion of 1,000+ commodities supporting
corporate name change project. Planned obsolescence budget $4 million. Actual obsolescence $400,000.
 Humira Packaging Line Consolidation – Lead $8 million capital project. Integration of 3 packaging lines into 1
continuous process with reduction of staff from 27 operators to 11. Drove operational equipment efficiency
(OEE) from 70% to 95%. Recognized for excellence with Division President’s Team Award for Operations.
 Six-Sigma Process Improvement for Tablet Printing of Niaspan – Resulting in process optimization and
decreasing cycle time for printing of over 1,000 lots. Elimination of all printing related product complaints.
Professional Experience:
Global Quality Director of Marketed Product Performance – Hospira, Lake Forest, IL (2014 – Present)
 Global Quality oversight for all products manufactured across 14 site international manufacturing network
(8,000 product SKU’s). Parenteral manufacturing of oncolytics, anti-infectives, pain and fluid management.
 Global Quality oversight for New Product Development across 4 R&D facilities (USA, India, Australia).
Responsible for establishing product specifications, critical quality attributes (CQAs) and critical process
parameters (CPPs). Quality Lead for Product Development and Global Expansion corporate governance.
 Resource Manager for Technology and Method Transfer. Ten direct reports ranging from Engineer to PhD.

2. Regional Operations Planning Manager – Abbvie, Lake County, IL (2012-2014)
 ERP/MRP Lead for 4 unique GMP manufacturing sites supporting >$10 billion in annual sales. API, Sterile
Manufacturing/Filling, Solid Oral-Dose Manufacturing, Finishing/Packaging.
 Production Master Scheduler for Finishing/Packaging Operation of 13 packaging lines, 400+ SKUs, >2,000
annual deliveries, $600 million material throughput supporting over $9 billion in annual sales.
 Lead Shop Floor Control (SFC), Master Production Schedule (MPS) and regional Sales and Operations Planning
(S&OP) Processes from execution of daily production schedule to 24 month rough cut capacity planning.
Operations Section Manager for Finishing/Packaging – Abbvie, Lake County, IL (2010-2012)
 Manager of 3rd
Shift Operations. Responsible for personnel development and annual performance evaluations of
60+ employees – line operators, production supervisors, equipment engineers and technicians.
 Member of 3-person management team responsible for 3-shift operation of 13 unique packaging lines with a $60
million annual budget, >$600 million in material spend supporting over $9 billion in annual sales.
 Subject Matter Expert for blister, bottle, syringe assembly and kit packaging processes and equipment.
 Implement programs to create sustainable workforce through development of training excellence curriculums
and establishing career progression plans from entry level to technical leads and supervision.
 Establish annual pricing standards and request for proposal of new products for new and existing customers.
 Led department in development and execution of over 30 successful new product launches.
 Led Total Productive Maintenance program to reduce equipment downtime by 30%.
Manufacturing Quality Manager – Abbott, Lake County, IL (2008-2012)
 Quality oversight of oral, solid/liquid dose manufacturing facility. Production of 600 million tablets, capsules,
granule and liquid doses annually by 50-member, 3-shift operation.
 Manage 24-hour Quality Control Laboratory and technicians responsible for in-process acceptance quality
testing (AQL), product release, product stability and equipment cleaning analytical testing.
 Author, approve and maintain Quality Manuals and Quality Technical Agreements for external customers.
 Conduct and approve manufacturing investigations and CA/PA.
 Author and approve Annual Product Quality Reviews (APQR) for internal and external customers.
 Site Complaint Manager responsible for staff executing all product complaint investigations, tracking and trends.
Site Validation Manager (2007-2008), Manufacturing Validation Supervisor (2006-2007), Cleaning Validation
Engineer (2005-2006) – Abbott, Lake County, IL
 Author, maintain, execute and defend site Validation Master Plan (VMP), Process Validation,
Equipment/Facility/Utility and Cleaning Validation protocols.
 Primary site interface with Regulatory Agencies (FDA, MHRA, ANVISA, Japan Tobacco, CVM).
 Member of Global Validation Expert Council to drive corporate validation policy harmonization.
 Leader of Materials Requirements Planning for Oliver Wight Class A site certification.
Senior Laboratory Analyst – Abbott, North Chicago, IL (2001-2005)
 Conduct in-process, final product release and product stability testing for oral and solid dose manufacturing and
consumer products.
 Analytical test method development and validation across a variety of wet chemistry and instrumental analysis
(UV/VIS, HPLC, GC, Dissolution, Particle Size Analysis, ICP, IR, Robotics).
 Author laboratory investigations for Out of Specification (OOS) and Out of Trend (OOT) results.
Education:
Masters of Business Administration – Lake Forest Graduate School of Management
Graduated with Honors
Lake Forest, Illinois (2012)
Bachelors of Arts in Chemistry and Minor in Mathematics
North Central College
Naperville, Illinois (2000)