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Quality Manager

Fox Lake, IL
135,000 - 150,000
June 11, 2018

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Mitchell Wheeler is a manufacturing, engineering, distribution, compliance and quality professional with over 25 years of industry and consulting experience in the pharmaceutical, medical device, supply chain and nutritional manufacturing arenas.

He is seeking a role that utilizes his skills and experience to develop, enhance and advise on best practices for healthcare industry quality systems, processes and operations.

Professional Summary:

Qualitas Compliance Services, LLC, Lake Villa, IL Aug 2016 – Present

Principal Consultant / Owner

Dohmen Life Science Services (DLSS), Milwaukee, Wisconsin Aug 2016 – May 2018

Senior Director – Corporate Quality and Continuous Improvement

Provide quality systems compliance support and regulatory expertise to Dohmen operations and quality teams. Conduct audits to identify and recommend corrective actions, develop quality plans and provide active support to Dohmen teams. Collaborate with and support quality systems development, quality investigation and improvement initiatives.

Key projects:

Led risk based quality audits of DLSS Operations designed to identify business critical issues. After review, the process was documented into policy level SOPs and forms.

Developed DLSS wide Continuous Improvement Program aligned with KPI measurements.

Performed monthly CAPA review meetings with the respective sites to review aging and status.

Developed strategy and documented plans to execute “team based” cross functional, risk-based internal quality audits annually across DLSS locations.

Oversaw validation documentation, testing and implementation of UL ComplianceWire across all Dohmen locations.

Lead the revision (to update to best practice) of approximately 85 policy level quality system documents and forms.

Serve as the Dohmen level system administrator for ComplianceWire and primary point of contact between Dohmen and UL Technical Support.

Performed engineering study and led blister packaging validation for pill dosing cards supplied as a service for client clinical trial studies.

AmerisourceBergen – PharMEDium Services, LLC, Lake Forest, IL Apr 2015 – Aug 2016

Sr. Quality Engineering Manager

Duties included serving as Sr. Quality System subject matter expert for quality system and formulation system service code change control, review and approval of drugs, diluents and other critical consumables for the production 503B sterile compounded pharmaceuticals.

Provided Memphis, TN, Cleveland, MS, Sugarland, TX and Dayton, NJ outsourcing facilities with ongoing corporate support on quality issues, and sustaining processes to support daily operations.

Reviewed and approved equipment and process validation protocols for accuracy, completeness and compliance to SOPs.

Wrote responses and implemented key processes to address FDA 483 observations, support commitments and best practices to improve quality, operational consistency and patient safety of sterile admixtures across PharMEDium facilities.

Key projects included the following:

oEnhanced change control process to better capture and document formulation changes.

oProvided validation oversight and review of automated filling equipment IQ, OQ and PQs.

oOversaw the quality review of new RFID label specifications and performed final approval.

oValidated labeling and scanning equipment for new RFID process.

oPerformed validation to confirm compatibility of new disposable compounding set materials.

oIn response to FDA observations, specified, purchased and validated PharMEDium first USP 1790 compliant visual inspection equipment.

oDesigned visual inspection challenge samples for training, identified consultant to create them “en masse” for all training teams within PharMEDium.

Regulatory Compliance Associates (RCA), Inc., Pleasant Prairie, WI Dec 2012 – Apr 2015

Consultant – Quality Specialist / Senior Auditor

Using risk-based approaches, assisted clients with the identification of compliance deficiencies. Assessed readiness for audits and inspections. Provided clients with the consulting expertise, tools, techniques and training to implement and/or remediate quality systems to current industry standards. RCA consulting roles were as follows:

Quality Specialist – Quality Plan Devel., Exsurco Medical - Birmingham, OH Mar – Apr 2015

Quality Specialist – QS Development, Hoof Health, LLC – Helenville, WI Jan – Apr 2015

3rd Party Batch Reviewer, Care Tech Labs, Inc. - St. Louis, MO Dec 2014 – Apr 2015

Interim CAPA Manager, Terumo Cardiovascular – Ann Arbor, MI Jun – Dec 2014

Quality Specialist, MD Custom Rx – Brookfield, WI Dec 2013 – Jan 2014

PwC-QS Devel./CAPA/Audit, Bur. of Engraving / Printing – Wash, DC Aug 2013 – Jun 2014

Supplier Auditor, Wellspring Pharmaceutical Corp – Sarasota, FL Jun 2013

CAPA / Root Cause Trainer - APIs, Fresenius-Kabi – Kalyani City, India Jun – July 2013

Interim Lead – OTC / Medical Devices, Triad Group, Inc. – Heartland, WI May – Aug 2013

Interim CAPA Mgr., AD–TECH Medical Instrument Corp., Racine, WI Jan – May 2013

cGMP Trainer – Medical Devices, Fresenius Kabi – Bensenville, IL Dec 2012 – Jan 2013

Commissioning Agents, Inc., Indianapolis, IN May – Dec 2012

Compliance Consultant – Alcon (A Novartis Company), Fort Worth, TX

Performed in-depth product review, trending and validation gap assessments per client specific protocols. Provided staff augmentation to assist clients with identified gaps with the quality system to integrate the client operations into the corporate quality system and standards. Developed SOPs for clients to comply with cGMP.

Assisted with product assessments providing general evaluation of the ability of sterile ophthalmic and injectable products to meet regulatory filings and design requirements throughout their shelf life. Compiled all review documentation guidance and standards into indexed, labeled objective evidence binders to support the assessment process.

Validant, San Francisco, CA / Chapel Hill, NC Dec 2010 – April 2012

Principal Consultant

Utilized my expertise and training in the industry to evaluate and implement compliant, sustainable pharmaceutical and medical device quality systems. In various consulting roles, provided guidance, direction, oversight and execution to meet regulatory timelines. Performed and documented analyses to identify and help create solutions to control, manage and eliminate gaps.

Validant consulting roles performed were as follows:

Quality Systems Lead – Omron Consumer Healthcare March – April 2012

Lake Forest, IL

oProvided industry standard guidance, direction and quality systems development for FDA, EU, ISO and overall global compliance.

oPerformed regulatory research, provided strategic direction and approaches to address new filings, registrations and submissions for the EU, Canada, Brazil and Mexico.

oDeveloped and revised FDA MDR and Vigilance decision tree questions and forms to document event reportability decisions.

Insp. Readiness Auditor – McNeil Consumer Healthcare Nov 2011 – Feb 2012

Fort Washington, PA

oReviewed, organized and compiled objective evidence of Process Validation / Quality Indicator Assessment (PVQIA) Reports. Developed documentation to summarize product assessment and market actions to help facilitate presentation to regulators or auditors.

oDeveloped and presented initial concept for PVQIA review protocol and form for confirmation of FDA consent decree plan commitments. Served on team of consulting professionals to confirm and assure readiness of work plan commitment documentation for regulatory review.

Sr. Reg. Compliance Consultant–Omron Consumer Healthcare Oct – Nov 2011

Lake Forest, IL

oPlanned and conducted FDA QSIT style audits of Complaint Handling, CAPA, MDR Reporting and Supplier Quality processes during the month of October 2011.

oThe objective was to assess updated complaint handling procedures and process implemented in August 2011 in response to 483 observations. During evaluation of Omron’s revised quality system, gaps were noted and recommendations were documented and provided for the further enhancement of organization’s processes and procedures.

Lead Consultant – Medela, Inc. Dec 2010 – Sept 2011

McHenry, IL

oFDA 483 / Warning Letter Remediation, Quality System Development and Inspection Preparedness. Developed sustainable quality systems as well as provided conservative guidance and oversight of FDA 483 and Warning Letter response and commitment completion.

oAs a lead consultant, performed CAPA, Complaint, MDR and Vigilance Reporting remediation, supplier quality system development, oversaw complaint backlog reduction planning and execution.

oAssisted with FDA and ISO audit administration. Responsibilities included logging, retrieval, review and preparation of documentation. Interfaced with regulators to support key complaint handling unit personnel with requests, inquiries and presentation of documentation. Conducted effectiveness audits of implemented complaint handling and vigilance reporting processes.

Baxter Healthcare Corporation – Corporate Quality

Global Field Surveillance, Round Lake, IL May – Nov 2010

Director – Corporate Product Surveillance Operations

Managed and directed the day-to-day Corporate Product Surveillance (CPS) teams responsible for the Medication Delivery and Renal Divisions’ complaint handling. Managed and sponsored internal process improvements and projects. Supported regulatory interactions as well as prepared / reviewed procedures and data for regulators during inspections. Participated in quality assessments of internal operations and suppliers to analyze compliance and assess risk.

Designed and executed a backlog reduction plan, reducing overall complaints by 13,200. Oversaw the execution and implementation of 100% review of all product complaints. Implemented an improved decision tree process to appropriately assess the MDR reportability of Renal and Medication Delivery product complaints. The CPS organization included 8 direct report supervisors and 137 complaint handlers on the various complaint handling teams in total.

Cardinal Health / Supply Chain Services

Quality and Regulatory Affairs, Dublin, OH / Waukegan, IL Feb 2006 – May 2010

Director, Quality and Regulatory – Midwest and Central North Regions –

Directed overall compliance, regulatory reporting and quality system activities of 17 Midwest and Central North Region distribution centers. Performed scheduled audits of Midwest and Central North distribution centers to verify compliance to regulations, corporate policies and procedures. Managed and monitored product and service complaints and CAPA via Cardinal Health developed web based applications.

Served as distribution network liaison and point of contact for CA Board of Pharmacy licensure and the National Association for Boards of Pharmacy VAWD accreditation programs. Hosted customer, regional corporate and regulatory audits of distribution facilities covering Cardinal Policy, Board of Pharmacy, DEA, FDA, and DOT regulations. Managed 5 direct report Compliance Officers and 12 dotted line reporting site representatives. As a Lean Six Sigma Sponsor I reviewed all pending projects for quality effectiveness.

Cardinal Health / Corporate Quality and Clinical Affairs

Global Reg. Compliance, Dublin, OH / McGaw Park, IL Mar 2004 – Feb 2006

Manager – Quality Assessments

Responsibilities included monitoring the cGMP compliance of 42 Pharmaceutical Technologies and Services (PTS) contract manufacturing sites domestically and worldwide. Monitored FDA international regulations, emerging trends and internal regulatory inspection activities. Products manufactured were solid/oral dosage forms, small-volume sterile injectables, blow-fill-sealed sterile ophthalmic as well as specialty contract packaging services.

Revised corporate GMP compliance policies as required to maintain regulatory compliance and communicate best practices to operations. Planned, conducted and reported on GMP assessments of PTS operations to facility, business, and corporate management. Performed assessments of contract service providers, Nuclear Pharmacy Services and raw material suppliers as required.

Performed training on CAPA and best demonstrated practices for documenting complaints and investigations in the Global PTS Track Wise Database. Provided training on GMPs and GMP auditing.

Abbott Laboratories / Hospital Products Division

Quality Assurance Services, Lake Forest, IL May 2003 – Mar 2004

Program Manager - Product Complaint Analysis

Managed the worldwide product complaint process for sterile drugs, disposable devices, coronary stents, and serialized devices for Abbott’s Hospital Products Division (now Hospira Corporation). Maintained responsibility for 44 direct reports across three global complaint handling operations in Abbott Park, IL, Morgan Hill, CA and Galway, Ireland.

Managed FDA inspections and interfaced with many customers and country authorities as they inquired about various complaints. Worked with the division recall coordinator and customer service to process recalls across approximately 500+ product codes. Compiled monthly and quarterly management review analyses and trending of complaints received. Implemented a risk analysis process to evaluate significant complaints received and to review investigation activities and progress.

Met weekly with Medical Affairs professionals to evaluate Health Hazard Risk Assessments and final MDR corrective action input (field H10) for MedWatch submissions. Administered and hosted weekly HPD “Field Failure” meetings to understand, document, evaluate, and assign RPN scores to complaints triggering our analysis.

Abbott Laboratories / Hospital Products Division, Abbott Park, IL Feb 2000 – May 2003

Program Manager - HPD Division Internal Audit

Devised, structured and administered the internal audit process for Abbott’s Hospital Products Division (now Hospira). Validated and administered Abbott Hospital Products’ electronic method for the global tracking and dissemination of all corporate, divisional as well as regulatory audit activities and commitments.

Performed ad-hoc quality evaluations for several pharmaceutical and medical device manufacturers and key suppliers either explored or used by Abbott. Assisted with the startup, acquisition, development, and maintenance of quality systems for various Abbott drug and device facilities. Served as part of Abbott’s Corporate “Team Validation” program. Managed 5 direct reports in this role.

Abbott Laboratories, Abbott Park, IL Aug 1998 – March 2000

Sr. Compliance Auditor - Corporate Regulatory and Quality Science

Our team performed compliance audits of all divisions of Abbott Laboratories. Our compliance program monitored sterile injectables, solid / oral dosage forms, corporate utilities (such as, water for injection oil free compressed air and nitrogen, etc.), infant formula/nutritionals, chemical and agricultural products, disposable and serialized medical devices, as well as in-vitro diagnostics.

Our team conducted corporate audits and FDA 483 remediation for all facilities. As corporate representatives we verified effectiveness and completion status of FDA 483 and Warning Letter commitments for Abbott Diagnostics Division’s 1999 FDA Consent Decree of Injunction.

Abbott Laboratories, North Chicago, IL Oct 1996 – Aug 1998

Industrial Engineer - Corporate Engineering Division (CED)

Supported Corporate Plant Engineering Operations with monthly performance measures reporting, work measurement studies and process improvements for North Chicago and Abbott Park maintenance organizations. Supported the global Calibration Task Force and helped facilitate the development and roll-out of e-CARS, an electronic routing and approval tool for calibration service requests and completed records.

Performed work sampling studies on skilled tradesmen to help them determine ways to improve their “wrench time” percentages, reduce “Mean Time Between Failure” and product failure issues for critical fermentation and Rapid Diagnostic testing equipment.

Over the course of two years in CED, I managed two Industrial Engineering student intern teams on projects to develop kits for fermentation tank PMs, improve the safety of chemical tank farms, and improve over travel time and parts procurement within the 9 MM square feet of facilities we were required to perform scheduled maintenance on.

Abbott Laboratories, Rocky Mount, NC Feb 1995 – Oct 1996

Manufacturing Quality Assurance Supervisor

Large and Small Volume Parenterals – Served as the primary quality assurance contact for night shift 12 hour operations in one of the largest sterile injectable manufacturing operations in the US (approx. 1 MM sq. ft. of sterile plant-now Hospira). Performed full batch record review and release for LVP, and conducted line clearance evaluations, finishing area audits, and finishing batch record and accountability reviews for SVP.

Served as night shift documentation SME; helped resolve various documentation discrepancies and needs concerning batch records, specifications, label facsimiles, etc. Served as the Large Volume business unit calibration coordinator managing over 400 pieces of scheduled calibrated equipment. Maintained “bad actor” lists and performed OOL investigations. Managed 9 direct report QA inspectors and coordinators within this role.

Abbott Laboratories, Rocky Mount, NC June 1992 – Feb 1995

Warehouse Supv. - Automated Storage / Conventional Ops. and Receiving

Managed 3rd shift inbound and outbound shipment of materials and finished goods for the Rocky Mount site and satellite facilities. Outbound shipment and storage of finished sterile injectables and medical device kits were managed via an Automated Storage and Retrieval System (ASRS).

Led slip sheet continuous improvement project which led to significant reductions in new pallet purchases and approximately 5MM in annual savings.

Developed the Customer / Loader Interface to provide a more customized approach to our customer service for large direct ship customers, such as, Duke University and Johns Hopkins Medical Centers.

Products manufactured and stored in various distribution center storage environments were injectable Rx drugs, controlled substances, and medical device kits.

Served as 3rd shift back-up supervisor for Abbott’s Cobalt 60 irradiation facility.

Organized and trained a self-directed work team for 3rd shift distribution that did not require supervision following my departure to my next role. Managed 13 direct reports in this role.

Abbott Laboratories, Rocky Mount, NC Oct 1988 – June 1992

Production Supervisor - Flexible Container Facility

Served as 3rd shift first line production supervisor involved with the manufacture of 1 000ml and 500ml IV solutions.

Following an extensive 9- month hands on management trainee program, was responsible for managing crews of production operators and line coordinators ranging from 50 to 100 in various sterile operations.

Production output at the time was 250,000 sterilized / packaged units per day. Total supervisory duties included solution preparation/filling, IV bag fabrication/printing, “over sealing”/sterilization and packaging.

Performed final product production batch record review and documented various deviation and nonconformance investigations and processed prior to final quality review and release.

Led cost reduction team to over 2 million dollars in continuous improvement savings on headcount and material.

Coordinated engineering and maintenance activities during scheduled facility shutdowns. Shutdown activities included maintenance of autoclaves, filler equipment, process piping, water systems, system PMs and other tasks.


M.S. Manufacturing Technology

East Carolina University - Greenville, NC (1992 – 1994)

B.S. Industrial Technology – Manufacturing

North Carolina A&T State University - Greensboro, NC (1983 – 1988)

Professional Memberships / Certifications:

American Society for Quality (ASQ) – Senior Member - Lake County Section 1212

PDA – Parenteral Drug Association

Regulatory Affairs Professionals Society (RAPS) Volunteer

Certified Quality Auditor – (ASQ-CQA) #28095

Certified Biomedical (Device cGMP) Quality Auditor (ASQ-CBA) #89

Certified Pharmaceutical cGMP Professional (ASQ-CPGP) #94

Certified Manager of Quality/Organizational Effectiveness (ASQ-CMQ/OE) #14385

PathWise Certified Investigations and CAPA Trainer – 2017 – Present

Currently Reviewing for ASQ Certified Six Sigma Black Belt Certification - 2018

Professional Organization Activities:

RAPS e-Learning Content Reviewer – Medical Device: Compliance and Audits – Fall 2015

Regulatory Affairs Professionals Society (RAPS) – Course Developer / Author – Medical Device: Compliance and Audits May 2012 – March 2013, August – December 2013

ASQ Biomedical - Body of Knowledge Review – Certified Biomedical Auditor Exam – August 2012

ASQ – Exam Reviewer – ASQ CQA / CBA – 2002 – 2018

ASQ Biomedical – Former Certification Board Chair – 2004 – 2006 – Rolled out the Certified Biomedical Examination (CBA) during my tenure.

National Association for Industrial Technology – Former Industry Representative / Accreditation Board Member 1996 – 1998. Performed Industrial Technology Program Accreditation

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