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Mike Neidig 06252015
- 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)