1. Mike Neidig, MBA
143 Dover Ave., La Grange, IL 60525 Cell: (630) 835-8117 email: email@example.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
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
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
Supplier Quality Assurance
API, Solid Dose and Aseptic Manufacturing
Enterprise Resource Management
Materials Requirements Planning
Risk Assessment (FMEA)
Mastery of Presentation Skills
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.
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
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.
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)