Glenn Wright Email & Phone Number

Bethesda, Maryland, Us

Bethesda, Maryland, Us

Bethesda, Maryland, Us

Leader of the Quality Function

Bethesda, Maryland, Us

Indianapolis, Indiana, Us

Responsible 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.

Indianapolis, Indiana, Us

Leading 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.

Indianapolis, Indiana, Us

Site 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.

Indianapolis, Indiana, Us

Management 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.

Indianapolis, Indiana, Us

Management 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.

Indianapolis, Indiana, Us

Management 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.

Indianapolis, Indiana, Us

Performing 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.

Bethesda, Maryland, Us

Providing 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.

Bethesda, Maryland, Us

Providing 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.

Thousand Oaks, Ca, Us

Performing 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

Thousand Oaks, Ca, Us

Management 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.

Thousand Oaks, Ca, Us

Developing, 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.

Indianapolis, Indiana, Us

Supervision 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.

Indianapolis, Indiana, Us

Developing and validating all new sterility test methods. Reviewing and evaluating all existing methods. Development of training course on method validation.

New York, New York, Us

Developing 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.