Glenn Wright Email and Phone Number
Glenn Wright's Location
Indianapolis, Indiana, United States, United States
Glenn Wright's Contact Details
Glenn Wright work email
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Glenn Wright personal email
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Glenn Wright phone numbers
About Glenn Wright
30 years’ experience advancing quality in biotechnology and pharmaceutical manufacturing. Comprehensive expertise in commercial and clinical trial manufacturing, quality management, auditing, regulatory, new-facility startup, facility remediation/modernization, and project/portfolio management.
Glenn Wright's Current Company Details
Glenn Wright Work Experience Details
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President & CeoPda - Parenteral Drug Association Mar 2023 - PresentBethesda, Maryland, Us
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Chief Operating OfficerPda - Parenteral Drug Association Apr 2022 - Mar 2023Bethesda, Maryland, Us
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Vice President Of Scientific And Regulatory AffairsPda - Parenteral Drug Association Mar 2020 - Apr 2022Bethesda, Maryland, Us
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Chairman Of The BoardProduct Quality Research Institute Mar 2021 - Present
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Sr. Director Quality OperationsExelead Jul 2018 - Jan 2020Leader of the Quality Function
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Business Development FellowPda - Parenteral Drug Association Jan 2018 - May 2018Bethesda, Maryland, Us
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Sr. Director/Adviser, Technical Services/Manufacturing Science - RetiredEli Lilly And Company Jun 2011 - Dec 2017Indianapolis, Indiana, UsResponsible for the creation and management of an integrated, Global Manufacturing, Post-approval, Technical Agenda valued at over 1 billion. Leadership of a cross-functional, organizational team, including members from Regulatory, Quality, Supply Chain, Technical Services and Manufacturing Science. Ensuring proper oversight, integration and delivery of the project portfolio spanning drug substance, drug product, and device. Developing and implementing a manufacturing facility’s first set of global, project-level management tools and custom, cost-effective software to provide the required level of governance and transparency. Advising on complex quality/compliance audits, high-impact projects and technical/organizational evaluations as directed by the Manufacturing Policy Committee. Maintaining external involvement in industry organizations to identify emerging industry and regulator trends related to quality, regulatory, and manufacturing. Leading industry committees and task groups to advance areas of interest for the company. -
Diversity And Inclusion LeaderEli Lilly And Company Feb 2014 - Nov 2017Indianapolis, Indiana, UsLeading the development and implementation an approach designed to build an engaged, inclusive and diverse organization. Implementing best-practices as well as identifying and connecting the many factors needed to advance these areas. Positive results have been seen in productivity and employee satisfaction.
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Sr. Director Quality Eli Lilly Italia (Site Quality Head)Eli Lilly And Company Sep 2007 - Jun 2011Indianapolis, Indiana, UsSite Quality Head for Eli Lilly's Italian Operations (Manufacturing, Testing, Marketing Affiliate, Third-party Contract Manufacturing Operations, Supplier Oversight, etc.). Management of the 100+ -member, QA/QC/Regulatory unit. Setting quality policy, auditing, making quality decisions and ensuring proper quality system oversight for all regulated areas (including: the demolition and re-purposing of the manufacturing site from dry products to sterile insulin filling, pen device assembly operations, laboratories, packaging, etc.). Setting strategy and engaging regulatory agencies for discussions related to quality/regulatory, including routine and PAI inspections. Auditing and/or advising other manufacturing sites as requested in the resolution of complex compliance or technical issues.
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Director Manufacturing Science And TechnologyEli Lilly And Company May 2004 - Aug 2007Indianapolis, Indiana, UsManagement of a 100+ -member, scientific function responsible for the technical transfers, process modernization, troubleshooting, trending, validation, qualification and restart of one of the corporation’s largest and most complex, parenteral manufacturing sites. Setting, prioritizing, and delivering on the site’s aggressive technical agenda related to significant compliance gaps identified by the regulatory agencies. Developing the company’s pre-filled syringe manufacturing strategy, including technical and design aspects as well as the capital investment strategy based on the developing product pipeline. Interacting with regulatory agencies for discussions related to compliance and manufacturing science. Auditing of manufacturing areas as part of an aggressive remediation program developed to resolve compliance issues identified by regulatory authorities. Active participation in regulatory inspections and discussions. Oversight of corporate QA Auditor training course.
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Director Global Regulatory AffairsEli Lilly And Company Jan 2002 - May 2004Indianapolis, Indiana, UsManagement of a 120-member, decentralized (members located at US and OUS manufacturing sites) post-approval, regulatory function responsible for all CM&C post-approval changes globally in addition to all new product applications in the intercontinental regions. Interacting with global, regulatory authorities regarding CM&C submission issues. Setting Lilly policy on CM&C post-approval change reporting. Active participation in the Lilly Corporate Specification Committee. Performing manufacturing and quality assessments for compliance-related issues. Participation in industry groups related to aseptic processing standards and post-approval change expectations.
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Manager Qc DevelopmentEli Lilly And Company Mar 1999 - Jan 2002Indianapolis, Indiana, UsManagement of quality activities related to the manufacturing, testing and development of drug products in all dosage forms—from phase I through phase III— including activities performed by CMOs. Auditing and resolution of quality and compliance issues both internally and at CMOs. Routinely interacting with FDA and other Regulatory agencies to discuss/resolve manufacturing and formulation issues. Performing due diligence audits for potential NBDs. Resolving quality issues and ensuring successful global PAI inspections of a CMO used for commercial manufacturing of a novel lifesaving product on a timeline pulled ahead by 1 year. This included the design of all front-room and back-room PAI inspectional processes, which were widely applied across the company.
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Corporate AuditorEli Lilly And Company Sep 1997 - Mar 1999Indianapolis, Indiana, UsPerforming audits of commercial and clinical API/final-dosage form for manufacturing operations and associated laboratories, including due-diligence audits for potential new business deals. Developing and implementing a corporate auditor training course. Consulting on design and operation of commercial and clinical biologic manufacturing facilities. Creating corporate standards for product development, clinical trial manufacturing, commercial aseptic processing, and bulk biologic manufacturing.
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Board Of DirectorsPda - Parenteral Drug Association Jan 2011 - Dec 2016Bethesda, Maryland, UsProviding active board oversight and assistance for PDA projects, budget and strategic planning. Elected to two, 3-year terms on the PDA Board of Directors. Retired from the board at the end of 2016 based on term limits, but remains an active PDA member.
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Board Of DirectorsPda - Parenteral Drug Association Jan 1998 - Dec 2003Bethesda, Maryland, UsProviding active board oversight and assistance for PDA projects, budget and strategic planning. Retired from the board at the end of 2003 based on term limits.
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Corporate AuditorAmgen Jan 1997 - Sep 1997Thousand Oaks, Ca, UsPerforming Amgen-site and vendor quality audits, both domestic and international. Performing due diligence audits for potential new business deals. Co-developing a standardized auditing program, supplier management program, and corporate auditor certification program. Raw material troubleshooting -
Qa/Qc Microbiology Lab Operations HeadAmgen Jan 1994 - Jan 1997Thousand Oaks, Ca, UsManagement of QA/QC Microbiology Laboratories with 5 supervisors and 35 bench analysts. Oversight of sterility testing, environmental monitoring, raw-material and in-process bioburden/LAL testing, preservative effectiveness testing, water testing, microbial identification, and particulate testing. Performance of critical, quality-related investigations involving manufacturing and filling areas. Auditing of vendor sites and Amgen manufacturing areas with members of the Amgen Auditing department. Assisting in the construction of PLAs and working with members of CBER and the FDA district office.
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Qa Microbiology Senior Project CoordinatorAmgen Jan 1993 - Jan 1994Thousand Oaks, Ca, UsDeveloping, staffing, and managing special projects in the QA Microbiology department using matrix management. Resolving startup issues at the company's commercial parenteral manufacturing site in Puerto Rico.
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Qc Qroup LeaderEli Lilly And Company Jul 1992 - Jan 1993Indianapolis, Indiana, UsSupervision of four, separate QC laboratory areas with a total of 14 direct reports. Oversight of culture preparation, media preparation, microbial antibiotic plate potency testing, and drug substance/drug product particulate testing. Performing audits and certifying foreign affiliates for various biological testing methods.
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Staff MicrobiologistEli Lilly And Company Jan 1991 - Jul 1992Indianapolis, Indiana, UsDeveloping and validating all new sterility test methods. Reviewing and evaluating all existing methods. Development of training course on method validation.
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Staff MicrobiologistPfizer Aug 1989 - Jan 1991New York, New York, UsDeveloping new assays, validating laboratory equipment, performing general laboratory and sterility testing. Reviewing standard test procedures and viable particulate monitoring of aseptic production areas and personnel.
Glenn Wright Skills
Fda
Validation
Quality Assurance
Regulatory Affairs
Gmp
Pharmaceutical Industry
Aseptic Processing
Biopharmaceuticals
Manufacturing
Quality Control
Capa
Process Improvement
Sop
Biotechnology
Technology Transfer
Clinical Trials
U.s. Food And Drug Administration
Project Management
Product Development
Management
Cross Functional Team Leadership
Microbiology
V&v
Change Control
Quality System
Regulatory Submissions
Drug Development
Life Sciences
Auditing
Drug Discovery
Supply Chain
Lifesciences
Environmental Monitoring
Corrective And Preventive Action
Glenn Wright Education Details
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Southern Illinois University, CarbondaleMicrobiology
Frequently Asked Questions about Glenn Wright
What company does Glenn Wright work for?
Glenn Wright works for Pda - Parenteral Drug Association
What is Glenn Wright's role at the current company?
Glenn Wright's current role is President and CEO at PDA - Parenteral Drug Association.
What is Glenn Wright's email address?
Glenn Wright's email address is wr****@****lly.com
What is Glenn Wright's direct phone number?
Glenn Wright's direct phone number is +131727*****
What schools did Glenn Wright attend?
Glenn Wright attended Southern Illinois University, Carbondale.
What skills is Glenn Wright known for?
Glenn Wright has skills like Fda, Validation, Quality Assurance, Regulatory Affairs, Gmp, Pharmaceutical Industry, Aseptic Processing, Biopharmaceuticals, Manufacturing, Quality Control, Capa, Process Improvement.
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