DeAngelo Tabor

Experience

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  Eli Lilly

  Aug 2000 - Sept 2005

  Third Party Supply Services Quality Control Representative

  Main Purpose:In conjunction with Lilly’s Third Party Manufacturers, provide quality oversight for the production of solid oral dose, sterile injectable, and human biological products at four third party manufacturing facilities. Key Responsibilities:• Acted as QC person in-the-plant for seven months on international assignment during the manufacturing of Lilly product released to the US market. Provided QC oversight, assistance and guidance in daily third party operation issues and final product disposition. Responsibilities included: maintaining presence on-site during manufacturing; providing guidance to quality issues potentially impacting (Safety, Identity, Strength, Purity and Quality) of the product, which included the review /approval of seven manufacturing investigations and three laboratory atypical reports with an average turnaround time of 2 to 10 days from review to approval; reviewed all batch records containing on average 300 pages per lot, three to five production event reports (know as deviations), and dispositioned 27 approved lots for release to the US market and reviewed 4 rejected lots.• Responsible person for global product recall which included determining the amount of lots impacted in the US market, second person verified lot information, communicated with Lilly Outside US packaging sites, reviewed and understood environmental monitoring data from technical investigation team, reviewed 3-Day Field Alert letter for accuracy and completeness of Lilly information, worked closely with corporate QA and all third manufactures involved to determine the root cause. • Reviewed and approved all batch records and supporting documentation such as fill, finish, laboratory, sterilization and packaging records, and disposition for release to US market. • Authored and reviewed change controls, deviations, procedures, product related investigations, product specifications and quality agreements. Show less

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  Elan

  Sept 2005 - Jun 2006

  Manager, Commercial Quality Assurance

  Main Purpose:In conjunction with Élan’s Third Party Manufacturers and Distributors, provide quality oversight for the production of solid dose and sterile injectable products at third party manufacturing and distribution facilities. Key Responsibilities:• Reviewed and approved all batch records and supporting documentation such as fill, finish, laboratory, sterilization and packaging records, and disposition for release to US and EU markets. • Authored and reviewed change controls, deviations, procedures, product related investigations, product specifications and quality agreements.• Lead or participated in third party manufacturer and regulatory audits of drug product, API, and excipient manufacturers. Audits include a thorough review of the site’s production process, batch-releasing procedures, batch record review, and overall compliance to cGMPs.• Maintained communication of quality issues with third party customers and Élan’s VP of Quality.• Participate and review quality and technical components of the Annual Product Review Report and Annual Report. Show less

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  Cardinal Health

  Jul 2006 - Jun 2007

  Director, Quality Assurance and Regulatory Compliance

  Main Purpose:Managed Quality Assurance and Regulatory Compliance program, monitored regulatory agency activities, and assured company procedures were in place to ensure compliance. Also interacted with Sales/Customers and internal production departments to ensure compliance with policies and procedures. Key Responsibilities:• Led quality assurance and regulatory compliance program including development of regulatory related SOPs, in-house and vendor auditing, complaint handling, equipment validation, GMP documentation, GMP/DEA labeling design and set-up, regulatory agency reporting requirements, supervising and training personnel, developing more effective QA procedures, and reviewing FDA/DEA industry trends, adhering to all FDA and DEA regulations and company policies.• Directly supervised the Manager, Quality Assurance and Regulatory Compliance and responsible for overseeing (12) Quality Assurance Coordinators at two facilities.• Analyzed, evaluated, and upgraded, as necessary, QA procedures.• Interacted with Operations to ensure all repackaging operations complies with the cGMPs and other FDA/DEA regulations.• Evaluated all new business activities for compliance restrictions and requirements.• Managed in-house and vendor audits for regulatory and cGMP/DEA compliance.Accomplishments:• Led National Association of Boards of Pharmacy (NABP) Audit and received accreditation for two facilities from the Verified-Accredited Wholesale Distributors (VAWD) program. The VAWD program provides assurance that the wholesale distribution facility operates legitimately, is validly licensed, and is employing security and best practices for safely distributing prescription drugs from manufacturers to pharmacies and other institutions. • Led two inspections from the US Department of Agriculture, Division of Food and Safety with zero significant findings. Show less

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  Novartis Animal Health

  Sept 2007 - Oct 2010

  Manager, Quality Assurance

  • Served as liaison of knowledge between corporate FDA initiatives and USDA site staff • Prepared and led USDA, FDA, CDC and Animal Welfare inspections with daily corporate update• Accountable for all aspects of Site quality management systems and overall product quality. Responsible and authorized to ensure processes needed for QMS were established, implemented, and maintained. Evaluated any need for improvement based on regulatory requirements• Responsible for establishment and execution of standards, policies and protocols related to Quality Operations, Analytical Laboratory, Supplier Quality, Environmental and Microbiology Laboratory, Quality Systems and Document Control• As Cultural Change Agent built strong relationships with internal site departments related to quality and compliance plans and professional attitude• Responsible for development of KPIs that allow for an accurate measure of the Quality Management system and its continual improvement• Ensured that all QA responsibilities including internal audits, investigations, complaints, CAPAs, change control, deviations, document control, metrics, etc. were implemented and maintained• Reviewed, negotiated, and approved supplier quality agreements• Ensured findings from corporate audits and regulatory inspections were investigated and mitigated, and that they are effectively communicated internally and externally Show less

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  Becton Dickinson (BD)

  Oct 2010 - Jul 2011

  Manager, Quality Assurance

  • Responsible for developing and maintaining plant strategic quality plan and policies.• Accountable for the effective execution of processes carried out under departmental leaders (Quality Engineering, Compliance, Quality Systems, Batch Disposition, Quality Control Labs, Operational Quality and Sterilization), by prioritizing and managing people, resources and budget to accomplish expected requirements and performance. • Provided leadership direction/objectives, coaching and personal development of Associates to perform to their best ability and meet both personal and plant objectives. Responsible for 88 Quality Associates covering multiple shift operations.• Acted as the plant “Management representative” for Regulatory authorities and customers, by hosting related audits and ensuring effective resolution.• Built an influential and effective network and communication with World Wide Quality and Regulatory functions, other plant Quality Managers and other key World Wide functions (R&D, Engineering, Supply Chain, etc.) in order to insure alignment around global and local priorities.• Accountable and successfully managed critical quality issues. Show less

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  Covance CLS

  Aug 2011 - Jun 2013

  Associate Director, Quality Assurance Americas

  • Responsible for identifying Quality Actions/Elements and execution of the CRO Business Unit strategy • Assured all GMP systems, processes and their outcomes comply with standards that meet applicable GCP, GLP and GMP regulations and guidelines; prepared and led FDA Pre-Approval Inspection, College of Pathologists, New York State, CLIA and multiple client audits• Reviewed modified in collaboration with Client Quality Leadership GCP and GLP study documents prior to study milestones • Escalated quality issues and presented metrics to Site and Executive Leadership• Responsible for the development of personnel to support the ongoing and progressive business needs, including identifying and developing successors for critical positions Show less

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  Johnson Controls

  Jun 2013 - Sept 2015

  Global Director of Quality & Compliance - Life Science/Pharma/Manufacturing - Indianapolis,

  Represents the primary relationship between global Client Quality representatives and Johnson Controls. Responsible for the development and implementation of the GWS LSAS Quality Management System managing the alignment to the clients Teams and JCI corp Quality Management Systems. Tracks and measures LS client team Audits and following investigation / action plans assuring services appropriate to the Life Sciences market. Evaluates, selects, implements and actualizes Best Practices across the Life Science CBG portfolio. Provides understanding and use of the customer satisfaction assessment process, the integration and reporting of on-going process measurements, and control plans. Oversees Client team CAPA / QI events for JCI deliverables as well as provide consultation and interfaces Site Team Quality Mangers / Directors. Show less

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  CBRE

  Sept 2015 - Dec 2015

  Global Director of Quality & Compliance - Pharma/Hospital Specialty Facility Solutions

  • Responsible for identifying Quality Actions/Elements and execution of the Pharmaceutical Facilities Management Business Unit strategy • Direct reports included 10+ Directors covering top 15 pharma accounts coving US, EU and Singapore • Accountable for all aspects of Corporate and Customer quality management systems and overall product quality. Responsible and authorized to ensure processes needed for QMS were established, implemented, and maintained; Evaluated any need for improvement based on customer and regulatory requirements• Escalated quality issues and presented metrics to Site and Executive Leadership• Ensure contracted activities for R&D and Commercial sites performed according to customer master agreements• Partnered with public relations, legal, and marketing to ensure proper messaging of media releases or customer notifications• Reviewed, negotiated, and approved Customer and Supplier quality or master agreements• Responsible for the development of personnel to support the ongoing and progressive business needs, including identifying and developing successors for critical positions Show less

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  Concentrics Research LLC

  Dec 2015 - Mar 2016

  Director, Regulatory Compliance and Quality Assurance

  Main Purpose:Responsible for leading, providing Quality/Compliance Clinical Trial consulting to internal departments and oversight of all quality assurance functions including regulatory compliance, standard operating procedures, training files, internal and external auditing, and corrective and preventive actions.Key Responsibilities:• Developed Strategic and Tactical Departmental Plan annually with goals and objectives • Created an annual FY budget for QA, including proposals and projections for any new needs in the QA Department.• Developed comprehensive vendor audit checklist to assure that vendor auditing is comprehensive and effective in monitoring the status of key processes and functions.• Assures regulated areas such as the drug room (storage, labeling, temperature/humidity) and document/records room (storage, labeling, long-term storage) are in continuous compliance.• Assures that departmental functions and processes are audited, results are tabulated and issues are identified and communicated to key parties (CEO and department managers). Show less

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  Singota Solutions

  Apr 2016 - Mar 2018

  Director of Quality Assurance and Regulatory Affairs

  • Responsible for identifying Quality Actions/Elements and execution of the Business strategy in collaborative fashion • Directly managed the Quality Unit which included a team of 1 Quality Manager & 7 indirect in 55+ person 72,000 sqft facility reports including: QA Manufacturing/ Validation/ Quality Systems/ Training and Document Control• Ensured compliance with regulations governing CDMO manufacturing, laboratory (QC) testing, warehousing and return of sterile parenteral preparations of Clinical Trial Material and Commercial Product to Client for final release to Client by performing the following routine activities:Daily Responsibilities: Monitored applicable revised or new regulations and guidelines governing Company’s operations and provide guidance to Leadership team for actions as applicable by reviewing Daily Federal Register Table via email for FDA regarding Proposed Rules and Notices. Managed Regulatory communications  Reviewed emails from internal departments and external Client/Supplier communications. Reviewed direct report’s PTO requests Provided daily guidance to Quality, Client Services, Supply Chain, Manufacturing and Laboratory departments Monthly Responsibilities: Reviewed, negotiated, and approved Client and Supplier Quality Agreements Chaired Quality Review Board regarding Client audit findings, Regulatory findings, deviation trends identified, ad hoc items, etc. Presented Quality issued metrics during SLT meeting Reviewed and assessed pest control form for approved pesticides by Engineering Monitored staff training compliance by pulling and viewing the Training Compliance Report, documenting the training review, and updating department managers as applicable Performed Laboratory oversight activities: Performed Warehouse oversight activities: Performed Sample and Dispensing oversight activities: Performed Internal and Supplier Audit activities using a systems-based inspection technique: Show less

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  Piramal Pharma Solutions

  Mar 2018 - Aug 2019

  Associate Director of QA

  • Also served as Director of Quality and Associate Director of Compliance and Regulatory Affairs• Directly managed the Quality Unit multiple times which included a team of 3 Associate Directors & 34 indirect in 160+ person 50,000 sqft facility reports including: Regulatory Affairs-Compliance/ QA Manufacturing/Validation)/ Analytical Quality Control Laboratory/ Microbiological and Environmental Monitoring Laboratory• Responsible for identifying Quality Actions/Elements and execution of the Business Unit strategy in collaborative fashion• Ensured compliance with regulations governing CDMO manufacturing, laboratory (QC) testing, warehousing and return of sterile parenteral preparations of Clinical Trial Material and Commercial Product to Client for final release to Client by performing the following routine activities:o Approver and communicator of critical Manufacturing Quality Issueso Reviewer/Approver of Facility/Equipment/Systems Protocol and Qualificationso Approver of Master Batch Record prior to issuance to Operations and approval of executed batch recordo Chaired of bi-monthly Change Control and CAPA Review Boardo Lead critical quality notifications to Clients by verbal communication and accordance to quality agreemento Approver of HEPA Certification and Calibration Reviewo Approver of Stability Protocols and Analytical Test Methodso Approver of Environmental Monitoring quarterly reviews• As Cultural Change Agent built strong relationships with internal site departments and external leaders related to quality and compliance plans and professional attitude• Managed third-party consultancy requirements for QMS and Data Integrity continual improvement projects.• Partnered with project management, legal, and marketing to ensure proper messaging of media releases or customer notifications• Reviewed, negotiated, and approved Customer quality agreements Show less

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  AmerisourceBergen

  Aug 2019 - Jun 2020

  Director of Quality (Pharmedium Business Closed)

  • Ensured remediation of Consent Decree compliance of aseptically prepared compounded products (503b) from supplied FDA approved finished products manipulated into branded Pharmedium finished products for hospital pharmacies, Responsible for closure of all Quality Systems and final document retention due to business closure• Directly managed a team of 5 Managers & 60 indirect in 175+ person 122,000 sqft facility reports including: Quality Operations/ Quality System/ Analytical Quality Control Laboratory/ Microbiological and Environmental Monitoring Laboratory/ Document Control• Responsible for identifying Quality Actions/Elements and execution of the Business strategy in collaborative fashion • Responsible for development of KPIs that allow for an accurate measure of the Quality Management system and its continual improvement• Ensured timely completion of routine QA/QC activities including internal audits, reporting of audit/inspection outcomes, investigations, complaints, CAPAs, change control, deviations, document control, reporting critical SISPQ to VP of Quality and VP of Technical Operations, metrics, etc. • Active leader on the site Leadership Team that provides strategic planning & sets policy. Also, a core quality technical partner with Operations & R&D providing influence to change• Ensured findings from audits and regulatory inspections are investigated and mitigated, and effectively communicated internal departments and VP of Quality and VP of Technical Operations• Participated in the in New Product Introductions process as a key input provider; Supported commercial initiatives by ensuring new products are introduced in compliance with cGMP requirements• Managed third-party consultancy requirements for addressing Consent Decree issues and or QMS continual improvement• As Cultural Change Agent built strong relationships with internal site departments and external leaders related to quality and compliance plans and professional attitude Show less

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  Greenfield Global

  Oct 2020 - May 2023

  Vice President of Quality

  Summary:Most senior Quality position within our business unit and is responsible for the overall performance and strategic direction of all quality related activities supporting the operations and commercial activities of Greenfield Global, USA. This includes oversight of the Brookfield, CT, Shelbyville, KY US facilities and start-up facility located in Ireland. Reports directly to the Executive Vice President and Managing Director of Specialty Chemicals and Ingredients for Greenfield Global, Inc. Portlaoise Ireland Greenfield manufacturing site occupies 40,900 ft2 and employs 45 employees, including 18 in QA/QC Shelbyville KY USA Greenfield manufacturing site occupies 150,000 ft2 and employs 70 employees, including 12 in QA/QC Brookfield CT USA Greenfield manufacturing site occupies 45,000 ft2 and employs 113 employees, including 21 in QA/QCSpecific Accomplishments:o Developed and presented Legacy & Operational Improvement Plan to CEO, Division President and Legal Counsel for obtaining Ireland Site ISO 9001 & EXCiPACT certifications; zero critical or major non-conformances for June 2022 audit & December 2022 audit. Specific Responsibilities:• Accountable for all aspects of BU quality management systems and overall product quality. Has responsibility and authority to ensure processes needed for QMS are established, implemented, and maintained. • Develop, implement, and communicate a clear strategic vision for US & Ireland sites to maximize employee alignment and engagement, and performance. • Articulate, model, and entrench a culture of safety, reliability, quality, and ethics aligned with Greenfield Global’s values. • Ensure compliance with all applicable quality standards (ISO 9001:2015, GMP, EXCiPACT, FSMA, Organic, and other certifying body requirements) while facilitating efficient business operations and supporting commercial growth and customer satisfaction. Show less

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  EVERSANA

  May 2023 - now

  Vice President of Quality