Quality Assurance Group Leader
Resume:
Charlie Neal, Jr.
Premier Quality Consulting
Cary, NC 27519
************@*****.***
CONFIDENTIAL
Page 1 of 6
Greetings Pharma! The reason for this communication is to inform you that I am offering my
contracting/consulting expertise to those of you needing assistance/direction in the following primary areas:
• Review of/advice on overall validation approach
• Review/generation of GMP validation-related
documentation. This includes master plans,
protocols, reports, summaries, deviations, exceptions, corrections, etc.
• Review/generation of GMP Policies, Standard
Operating Procedures
• Review of Quality Systems
Have been involved with validations since 1980. Have worked for a host of well-known pharma and biotech companies and CMOs in the areas of Research, Quality, Validation, Manufacturing and Sales and Marketing. Bringing over four (4) decades of industry experience, chances are good that I have faced your challenge or a variation of your challenge at some point along my journey. So, if you need assistance with any of the areas above—or any others—please reach out to me.
Charlie Neal, Jr.
Premier Quality Consulting
Cary, NC 27519
************@*****.***
CONFIDENTIAL
Page 2 of 6
Professional Summary
Youthful technical professional with over 30 years of experience in GMP-regulated industries. Possess strong people and people management skills. Have performed process development, scale-up, optimization, technology transfers, and validations. Hands-on technical experience acquired by working in sterile drug, chemical, med-device, pharmaceutical (API, solid dosage, liquids), and bio-tech industries. Bio-tech experience attained by providing management and oversight for a CMO’s qualifications and process validations. Presented papers on Technology Transfers (Japan), Process Validation and Validation Documentation. Mastered Vendor Management/Qualification, including Supplier Quality Agreements. Have held lead positions in Research, Development, Process Engineering, Manufacturing, Validation, Quality Assurance, Compliance, and Sales and Marketing. Have been heavily involved with sterilizations (EtO, Dry Heat, Steam and Irradiation) and lyophilization. Strong familiarity with Six Sigma and Lean tools. Possess strong Negotiation Skills. Well versed in SharePoint, TrackWise and Risk Assessments. Authored chapter on Transdermal Process Validation (published in the 3rd edition of “Pharmaceutical Process Validation”). Former member of the Institute of Validation Technology’s Editorial Board. Owner and Consultant for independent consulting firm. Skill Sets
HIGH-LIGHTS
• Amassed extensive experience in areas of Quality Systems Documents, Quality Assurance, Validation, Tech Transfers, Reviewer/Verifier/Approver, Investigations, Batch Record Reviews, Process Engineering, Compliance, Development, and Manufacturing
• Have worked with APIs directly and indirectly since 1980
• Have managed Vendor Qualification activities for a CMO
• Have performed Commissioning and directed FATs and SATs
• Nurtured strong relationships with all customers
• Have worked for several well-known Consulting companies in Management roles as well as for own, independent consulting firm
• Years in industry have resulted in a strong Quality mind-set SUMMARY
Quality Assurance Validation, Quality Assurance, QA Reviews, Quality Systems, Investigations, Batch Record Reviews, Document Reviews and Verifications, Quality Management Systems, Compliance, Vendor Management Qualification, Creating/Managing Supplier Quality Agreements, Technology Transfers, Process Engineering, Manufacturing Support, Sterile Drugs (including Vaccines) Support, Bio-Tech and Pharmaceutical Process Validations, EU Assessments, Technical Writing, Validation Project Management, Validation Mentor-ships, Negotiations, Communications, Periodic Reviews, Project Management (PMP Trained), Technical Leadership, Risk Assessments, Master Inventory Lists, ASTM E-2500 Implementation, Oral Dosages, Commissioning, FATs/SATs, Equipment Qualification, Validation Master Plans, Transdermal Process Validation, Cleaning Validation (Manual/COP), FDA/International Regulatory Guidance, Design of Experiments, Proposal Generation/Review/Issuance, Deviations, CAPAs, Product Life Cycle, Sterilizations, SOP Development, Process Scale-ups, Cross- functional Teams, Process Development, Process Optimization, Chamber Mappings, SharePoint, TrackWise, Veeva Vault, Pharma and Bio-tech CMOs Professional Experience
June 2022 to (present)
Resilience, Durham, NC—Technical Quality Resource
• Serving as a Quality Assurance Validation resource charged with review and approval of GMP/Quality Systems documents (protocols, reports, SOPs).
• Providing expertise on validation issues and activities conducted under GMP. February 2022 to May 2022
Thermo Fisher, Greenville, NC—Quality Assurance Deviation Investigator
• Worked with newly formed team investigating and resolving deviations.
• Resigned from job as a result of family emergency. Charlie Neal, Jr.
Premier Quality Consulting
Cary, NC 27519
************@*****.***
CONFIDENTIAL
Page 3 of 6
July 2021 to February 2022
Fresenius Kabi, Melrose Park, IL—(QD Design) Tech Transfer Consultant
• Worked with Tech Transfer department in investigating and resolving deviations. Project initially identified as short-term project (less than 4 months) to assist in reducing manufacturing/process related deviations. However, duration currently exceeding 5 months.
• Deviations required use of Track Wise system, which served as a repository for deviations and on-going investigations.
• Extensive validation experience aided in zoning in on root-causes, leading to faster deviation resolutions. My presence has had a positive impact on reducing overall deviations. January 2021 to April 2021
ANTARES Pharmaceuticals, Minnetonka, MN—(Independent) Senior QA Consultant
• Worked with Medical Device company on short term project (less than 4 months) to approve facility qualification documents
• Generated Quality System documents and served as Verifier/Approver for documents generated by others April 2018 to October 2020:
Xellia/Sagent Pharmaceuticals, Raleigh, NC—(Independent) Senior QA Consultant
• Responsible for Quality Assurance Validation for Qualification, Process Validation, and Tech Transfer activities
• Worked seamlessly with Tech Transfer and Validation groups, turning around critical documents received for approval within one day.
• Served as Compliance resource
• Performed Vendor Management/Qualification
• Generation/Management of Supplier Quality Agreements (>100) for CMO
• Conducted batch record reviews
August 2016 to March 2018:
Xellia Pharmaceuticals, Cleveland, OH—Validation Reviewer/Technical Resource
• Supported start-up of aseptic manufacturing process for site that is under Consent Decree
• Performed Technical Reviews for aseptic equipment qualification and process validation effort
• Worked within focused system to generate Operational SOPs for company recovering from Consent Decree
• Provided leadership to Operations group on compliance, quality, technical and validation issues Xellia Pharmaceuticals, Raleigh, NC—Quality Assurance Compliance Specialist (August 2016 to December 2016)
• Performed QA reviews for ongoing qualifications and process validations for sterile products.
• Responsible for initiating, presenting (to Change Control committee) and tracking Change Controls for new equipment and equipment changes in Trackwise.
• Responsible for leading formal Risk Assessments.
• Responsible for reviewing site SOPs for accuracy and offering professional feedback.
• Responsible for Vendor Management/Qualification
March 2016 to June 2016: Kremers Urban—Senior Validation Consultant
• Responsible for overseeing and summarizing ongoing solid dosage process validations March 2014 to March 2016: ProPharma Group, Overland Park, KS—SE Region Area Manager/Sr. Project Associate
• As Regional Sales Manager, created strong client relationships and generated new business
• Generated, approved and issued client service proposals
• Managed regional budget
• Performed EU Compliance audit
• Performed Periodic Review and GAP Assessment for client Quality System
• Generated Master Inventory Lists
• Revised and generated client SOPs to assure audit readiness
• Developed ‘Position Paper’ for packaging contractor for presentation to regulatory bodies
• Executed Vendor IOQ for data loggers; mapped chambers using data loggers Charlie Neal, Jr.
Premier Quality Consulting
Cary, NC 27519
************@*****.***
CONFIDENTIAL
Page 4 of 6
January 2013 to December 2013: Mallinckrodt/Covidien, Raleigh, NC—Independent Senior Consultant
• Provided consultation to API manufacturer’s internal qualifications and process validations.
• Revised validation and re-validation SOPs.
• Revamped internal re-qualification program for equipment (inclusive of process equipment, instruments, and computer systems).
• Performed Validation Risk Assessments/audits and System Impact Assessments. July 2012 to December 2012: Genzyme/Advent Engineering, Boston, MA—Consultant/CQV Lead
• Lead/directed daily activities of CQV engineers on Consent Decree project.
• Managed team in a fast-paced, ASTM-E2500/Integrated C&Q environment.
• Authored and executed utility and equipment protocols and authored reports.
• Provided daily project status/updates to Senior Management. April 2012 to July 2012: Genentech/Advent Engineering, Portland, OR—Senior Project Manager
• Provided support to permanent Project Manager.
• Coordinated launch of high visibility, biotech derived oncology drug.
• Convened regular update meetings with core team members. July 2011 to April 2012: Sanofi/Advent Engineering, Swiftwater, PA—COP Validation Lead
• Led effort to develop and validate manual clean-out-of-place methods for vaccine product equipment.
• Managed day-to-day activities of and provided direction to 18 contractors.
• Generated and maintained resource schedules for cleaning operations.
• Approved development and validation documentation.
• Initiated deviations and worked with Quality, Technical Operations and Manufacturing to attain closure. June 2011: Covidien/Jacobs Engineering, Raleigh, NC—Senior Validation Consultant
• Wrote Validation Master Plan for plant revalidation. July 2010 to November 2010: Hospira, Rocky Mount, NC—Senior Validation Consultant/Compliance Director
• Performed Project Management for large Tech Transfer/validation projects (involved transfer and validation of equipment from continental US to Caribbean site).
• Managed inspection of vials and ampoules with automated vial inspection equipment.
(Note: attempted to launch personal product from November 2010 to June 2011) October 2009 to June 2010: Sandoz, Wilson, NC—Senior Validation Consultant/Compliance Director
• Performed Tech-Transfers, process optimizations, process and cleaning validation.
• Created/implemented GMP documents (batch records, tech transfer documentation, protocols, and reports).
• Assured that project documentation was compliant with internal procedures and regulations.
• Administered trainings on newly created Formulation Batch Records, SOPs, and Protocols. November 2008 to September 2009: NNE Pharmaplan, Clayton, NC—Senior Consultant
• Assisted with implementation of ASTM E2500 verification approach at client facility.
• Traveled regularly to Asia to oversee and approve Quality Management System implementation/adherence.
• Upgraded and administered internal QMS and GMP trainings.
• Created accessible Global sales aide (for) Global corporate resources. Charlie Neal, Jr.
Premier Quality Consulting
Cary, NC 27519
************@*****.***
CONFIDENTIAL
Page 5 of 6
December 2007 to November 2008: NNE Pharmaplan, Clayton, NC—Regional Validation Manager
• Provided management and leadership to team consisting of full-time and contract employees.
• Revised client-based documents to reflect new ICH Q9A, Draft Commissioning and Qualification Guide and ASTM E2500 guidelines.
• Generated, approved and issued client service proposals May 2007 to November 2007: Pacific Bio-Development—Senior Validation Consultant
• Provided QA review of processing/batch records and validation data. May 2005 to April 2007: Diosynth-RTP—Sales Development Manager
• Provided sales support for Sales & Marketing Department.
• Authored proposals with an average annual value over $100 million.
• Identified and implemented measures to increase departmental efficiency and productivity. May 2003 to May 2005: Diosynth-RTP—Manager, QA Validation
• Provided QA and Compliance oversight to and direction for qualifications and process validations for Bio- tech CMO.
• Implemented validation guidelines, policies, procedures and master plans.
• Responsible for plant wide QA compliance.
April 2001 to May 2003: Diosynth-RTP—Manager, Capital Projects Equipment Qualification
• Managed team consisting of permanent and contract resources for Bio-tech CMO.
• Collaborated with Quality to define/establish strategy for qualifying Bio-tech equipment.
• Collaborated with key departments to implement new validation tools and standards.
• Instituted communications forum for operations management.
• Prepared subordinates for periodic Bio-tech regulatory audits.
• Represented Equipment Qualification in regulatory and client inspections/audits. June 1999 to April 2001: BE&K Engineering, RTP, NC—Validation Lead
• Provided quality and validation consulting.
• Wrote Validation Master Plans for multi-million dollar projects.
• Designed, qualified and implemented innovative QC tool for routine sampling. August 1993 to May 1999: TheraTech, Inc., Salt Lake City, UT— Senior Validation Engineer/Associate Director, Transdermal Development; Department Head, Validation and Production
• Responsible for manufacturing processes functioning properly and delivering quality product.
• Collaborated with Quality to enforce Corporate Qualification and Process Validation Policy and Corporate Validation Change Control Policy, which were authored by me.
• Facilitated internal development-to-manufacturing technology transfers.
• Prepped Validation Department for Pre-Approval Inspections (PAI).
• Represented Transdermal Validation in PAIs.
• Developed/implemented strategy for equipment qualification and process and cleaning validations for start-up company.
• Created and implemented validation program which included a documentation system complete with corporate level, transdermal-specific process validation procedures. September 1989 to August 1993: Marion Merrell Dow, Kansas City, MO—Senior Process Engineer/Project Manager
• Coordinated tech-transfers of processes from Development to Manufacturing and from US to Europe.
• Authored validation protocols, summaries and manufacturing records for sterile drugs, devices, solid dosages and liquids.
Charlie Neal, Jr.
Premier Quality Consulting
Cary, NC 27519
************@*****.***
CONFIDENTIAL
Page 6 of 6
• Implemented process for new, sterile injectable product at international site.
• Managed successful market launch of high-volume heart drug.
• Managed execution of equipment qualifications and process validations. June 1980 to September 1989: Bristol Myers, Evansville, IN—Senior Process Engineer
• Supported sterile drugs, solid doses, and liquids.
• Collaborated with Quality to define/establish strategy for equipment qualification and process validation.
• Authored qualification and process validation protocols/summaries and manufacturing records for sterile drugs, solid dosages and liquids.
• Executed equipment qualifications and process validations.
• Led Tech Transfer for sterile oncology product from IN to Caribbean site, developed and implemented novel lyophilization process.
November 1978 to June 1980: 3M, St. Paul, MN—Process Development Engineer
• Researched, developed and optimized synthesis routes for photographic film dyes in laboratory environment.
• Scaled-up processes and coordinated transfers to Pilot Plant. Presentations/Publications
• “Back to the Basics: Validation 101: An Overview of Installation Qualification, Operational Qualification, and Performance Qualification”, Journal of Validation Technology ‘97.
• “Technology Transfers in the Pharmaceutical Industry”, Journal of cGMP Compliance ‘98.
• “Equipment Cleaning Validations for Transdermal”, Journal of Validation Technology ’98.
• “Ensuring Completeness in Technology Transfers”, Institute of International Research Technology Transfer Conference, Atlanta, GA., Spring 1999.
• “Ensuring Completeness in Technology Transfers”, Japanese Pharmaceutical Symposium, Tokyo, Japan, Summer 1999.
• “Transdermal Process Validation”, 3rd Edition of Pharmaceutical Process Validation ‘03.
• “Prerequisites for Successful Validations”, Journal of Validation Technology ‘03.
• “Protocol Basics”, Compliance in Life Science Manufacturing Conference, Jersey City, NJ, Spring 2004.
• “Case Study: Cubic Equipment Qualification”, Annual Validation Week conference, Philadelphia, PA, Fall 2004.
• “Case Study: Cubic Equipment Qualification”, Journal of Validation Technology ‘05.
• “Engineering Runs: An Insider’s Perspective”, Journal of Validation Technology ‘06.
• “Challenging a System’s Performance as Part of the Validation Process: Optimizing Testing for Validation”, Annual Validation Week conference, Philadelphia, PA, Fall 2007.
• “IQ/OQPQ” presentation for Center for Professional Advancement (CfPA) Client, Summer 2019
• “IQ/OQPQ” presentation for CfPA Client, Winter 2019
• “IQ/OQPQ for Process Validations” presentation for CfPA, Spring and Fall 2020
• “IQ/OQPQ for Laboratories” presentation for CfPA, Summer 2020
• “IQ/OQPQ for Process Validations” presentation for CfPA in Spring 2021, 2022, 2023, and 2024 Education
• B.S. Degree in Biomedical Engineering from Louisiana Tech University, Minor in Chemical Engineering.
• Diosynth RTP Negotiations Program, Certification from UNC Kenan-Flagler Business School, February 15, 2007
• Preparatory course for PMP Certification
• Computer System Validation Course, NC State, September 2015 Charlie Neal, Jr.
Premier Quality Consulting
Cary, NC 27519
************@*****.***
CONFIDENTIAL
Page 7 of 6
Training
• Public Speaking
• Technical Writing
• Time Management
• Project Management
• Microsoft Excel
• Basic Biotech
• Quality Management System (QMS)
• ASTM E2500
• Numerous qualification and validation courses
• Numerous cGMP and Environment Health and Safety Training courses (internal and external client sites)
• Numerous PLC, Control Systems/Automation, and Computer System validation courses
• Over 40 years in the industry
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