Myles Kramer
Vice President Quality Assurance at Verrica Pharmaceuticals- Claim this Profile
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Bio
Credentials
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ASQ Certified Quality Auditor
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ASQ Certified Quality Engineer
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ASQ Certified Quality Manager
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Experience
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Verrica Pharmaceuticals
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Vice President Quality Assurance
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Jun 2022 - Present
Promoted to Vice President of Quality in June, 2022
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Executive Director, Quality Assurance
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May 2021 - Present
Leads the overall Quality System Management for the company. Responsible for the Quality oversight of third party manufacturing, packaging, testing and distribution of intermediate and finished Dermatological topical combination drug/device products, as well as managing Quality Assurance for R&D and new product development activities. Manages a team of Quality professionals in the areas of Product Quality Complaint Handling, Deviation management, CAPA systems, Stability monitoring program, APR and AR data collection and review, as well as establishing and managing the overall Quality Management System. Show less
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Amneal Pharmaceuticals
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Director, Head of Quality for Third Party Manufacturing
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Jul 2017 - Dec 2020
Responsible for the Quality oversight of over 35 Third Party Contract Manufacturers, Packagers and Testing Laboratories, consisting of 90 product families and 1,100 product SKUs. Product mix of solid IR and ER dose tablets and capsules, ODT products, oral contraceptives, inhalation suspensions, powders for injection, topical creams, gels and liquids, and a pre-filled epinephrine pen. The team managed a high volume of change controls, product quality complaints, deviations and CAPA, stability, APRs and AR data gathering. Show less
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Impax Laboratories
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Senior Director, Site Head Of Quality
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Mar 2015 - Dec 2017
Responsible for the Manufacturing site's Quality departments which included Quality Assurance, Incoming Quality, Quality Control laboratories, Regulatory Compliance and Quality Systems (90 associates in total). Was responsible for overall site Compliance. Prepared the site for and hosted all regulatory agency PAI and general inspections. Responsible for the Manufacturing site's Quality departments which included Quality Assurance, Incoming Quality, Quality Control laboratories, Regulatory Compliance and Quality Systems (90 associates in total). Was responsible for overall site Compliance. Prepared the site for and hosted all regulatory agency PAI and general inspections.
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CorePharma®
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Senior Director, Regulatory Compliance
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Mar 2014 - Mar 2015
Responsible for the Quality Systems and overall Compliance for the site. The Quality Systems included Complaint Handling, CAPA, Supplier Quality Management, Internal Auditing, Documentation Management, Training, Change Management and Computer System Validation. Responsible for the Quality Systems and overall Compliance for the site. The Quality Systems included Complaint Handling, CAPA, Supplier Quality Management, Internal Auditing, Documentation Management, Training, Change Management and Computer System Validation.
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NorthPoint Integrated Resources Consulting, LLC
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United States
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Utilities
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President
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Mar 2011 - Mar 2014
Operated NorthPoint Consulting LLC for 3 years; My work over this time has been with clients within the Pharmaceutical industry, within various areas of Manufacturing, Packaging, Contract Manufacture and Quality Assurance environments. I have provided assistance in the following specific areas: Quality System Evaluations (QSE); Comprehensive Product Analysis and Trending assessments (CPAT); Interim Controls (IC) Team Lead for Deviations, Validation, Change Controls and Laboratory OOS; Deviation Investigator Certification Program; Process Improvement Remediation Project Team Lead - Deviations and CAPA As Team Lead for the Deviations and CAPA project, I enabled the site to transform the way in which deviations were discovered, communicated, triaged and investigated. Show less
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Roche
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Switzerland
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Biotechnology Research
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700 & Above Employee
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Senior Director, Quality Management
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Jan 2004 - Mar 2011
Led the daily operation of Quality Assurance Departments supporting Manufacturing, Validation, Analytical QC Testing, LIMS/SAP interface systems and Quality Engineering.
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Director, Quality Assurance
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Jul 2001 - Jan 2004
Oversight of the Quality Assurance and Quality Engineering departments, providing Quality support to three (3) internal sites. Implemented and managed the Quality and Compliance relationship with two critical contract manufacturing partners.
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Education
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Lehigh University
Master of Science - MS, Quality Engineering -
Albright College
Bachelor of Science - BS, Biology -
Lehigh University
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Seton Hall University
Graduate School Courses, Advanced Biology -
Seton Hall University
Graduate School, Biology, General
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