John Kohn Email and Phone Number
John Kohn's Location
Folly Beach, South Carolina, United States, United States
John Kohn's Contact Details
John Kohn work email
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John Kohn personal email
n/a
John Kohn phone numbers
About John Kohn
Quality Assurance professional with over 30 years in the pharmaceutical/vaccine area with 28 of those years in the Quality arena and 26 years performing GCP related activities and auditing.
John Kohn's Current Company Details
John Kohn Work Experience Details
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Executive Director, Head Of Quality AssuranceDevpro Biopharma Aug 2020 - PresentBasking Ridge, Nj, Us
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Director, Clinical Quality Assurance And CompliancePearl Therapeutics, Division Of Astra Zeneca Mar 2015 - Jul 2020General management of the GCP QA & Compliance group as well as liaising with other Pearl divisions, partners and vendors. Develop and implement Pearl's GCP compliance strategy. Authors and/or revises Quality System Documents (GCP). Manages, conducts and/or participates in regional/global GCP Audits (e.g.; clinical study sites, vendors, CROs, IRBs/ECs, internal systems/procedures, submission documents). Manages internal QA staff, identifies and manages external audit resources to implement existing audit plans. Trains internal QA staff and contractors and/or consultants to ensure complete and accurate performance of assignments. Assures consistency and appropriateness of audit observations, reports and/or compliance assessments for GCP audits. Manages tools to track, trend and report GCP Audit data, provides meaningful metrics to management for use in systemic issue identification and resolution. Accountable for monitoring adherence to company policies and applicable regulations and taking action in non-compliant situations. Plans, schedules and conducts NDA PAI readiness activities. Provide inspection support at clinical sites and for internal clinical team during Federal/regulatory inspections. Interacts with Federal/regulatory representatives during inspections. Summarizes compliance risks for projects and/or regulatory submissions, identifies process improvement opportunities and assures implementation of CAPAs. Provides guidance regarding quality and compliance in GCP areas and provides GCP subject matter expertise to other areas within QA. Develops GCP audit schedule for QA management approval, with input from functional area customers. Reviews and audits clinical documents and records as necessary. Conducts and coordinates GCP compliance and quality training to QA staff, functional areas and external customers as requested (e.g.; Investigator meetings, Project team meetings, etc.).
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Associate Director, Global R&D QaNps Pharmaceuticals May 2014 - Mar 2015Bedminster, New Jersey, UsManage GCP and GLP functions for global compliance of quality systems/processesConducts audits of R&D vendors, CRO, investigator sites, protocols, Central Files, clinical and nonclinical study reports, submission documents, etcProvides QA leadership as a consultant member on project teamsAssists in resource forecasting and project prioritization Advises Senior Management on tactics to improve GCP/GLP compliancePartner with R&D to assure inspection readiness and serve as a liaison with Health Authority Agencies and assures control of activities during inspections and assists with co-ordination of responses Contributes and participates in compliance reviews for trending purposes -
Independent Gcp ConsultantKohn Gcp Consulting Aug 2013 - Apr 2014Provide Good Clinical Practice (GCP) and compliance services to the pharmaceutical, vaccine, biotech health care industries. These services include: GCP audits: investigative site, clinical vendor/CRO, IRB, Systems, CSR, TMF, Phase 1 units, databases, ISS/ISE, etc)Inspection Readiness for Investigator Sites/Vendors/CROs and Sponsors/CROs - "Mock"InspectionsClinical vendor and CRO selection and qualification GCP trainingReview of Clinical Study Documents (protocols, Informed Consents, Operating Guidelines, Case Report Forms, Investigator Brochures Monitoring Plans, etc)Development and Review of Quality Metrics and Quality System ImprovementsSOP review and development
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Global Senior Director, Clinical & Medical Quality OperationsSanofi Pasteur Jan 2013 - Aug 2013Paris, France, FrProvides CQA/GCP leadership and direction to concerned R&D and Clinical and Medical departments for quality and compliance practices/systems so that quality practices are developed and maintained throughout global clinical development and pharmacovigilance, regulatory and medical processes on all sites and affiliates of sanofi pasteur. Establish and monitor effective compliance programs in the GCP continuum from clinical research to post marketing surveillance. Leadership for quality to be provided through facilitation and training. -
Director, Quality Assurance North AmericaSanofi Pasteur Sep 2005 - Dec 2012Paris, France, FrProvide day to day leadership, management and strategic planning and the execution of activities within R&D CQA in North America. Supported clinical research department’s initiatives and activities and provided expertise and guidance for CQA’s auditing programs, quality metrics and quality systems improvements. I took a lead role during regulatory, corporate or other external audits of clinical research. Also, developed standard training for CQA auditors, GCP training for Clinical/Medical Affairs and GCP training for Principal Investigators. The key leader in clinical quality resolution at the clinical team level and contributor site and global projects
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Director Qa North AmericaMds Pharma Services, Late Stage Development Jan 2002 - Sep 2005Provide direct compliance and investigative support to areas of research operations which are effected by US and/or international regulations/guidelines. Educated, evaluated and managed North American QA personnel. I represented the company as a liaison for CRO assessments, sponsor or FDAaudits/inspections. Also, assisted in the development of action plans undertaken in response to regulatory audits or perceived corporate deficiencies. In addition, I performed various internal and external audits.
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Gcp Qa AuditorMds Pharma Services Oct 1997 - Dec 2001King Of Prussia, Pennsylvania, UsPerformed external audits (vendors, IRB, investigator sites, etc.) to establish compliance with ICH/GCP, IND regulations, SOPs and document the issues and performed system audits on project-specific systems (study files, databases, computer validation, training, tracking and filing of documentation, etc.) Also, reviewed study documents (protocols, Informed Consents, Operating Guidelines, etc) for consistency prior to study start up. Assisted in the development of action plans undertaken in response to regulatory audits or perceived corporate deficiencies. Prepared monitors and study sites for sponsor or FDA inspections and provided GCP training to monitors both in-house and at the investigator site -
Senior Associate, Quality ServicesCovance Clinical & Periapproval Services Nov 1996 - Oct 1997Perform external audits (vendors, IRB, investigator sites, etc.) and document issues. Also reviewed and documented findings for primary study deliverables (protocol, Clinical Trial Reports, Case Report Forms, sample consents, etc.). Performed internal audits (study files, databases, etc.) and document issues. Prepared monitors and study sites for sponsor or FDA inspections and provided GCP training to monitors both in-house and at the investigator site. Also, provided guidance to project teams on related quality and compliance issues and assisted management in overseeing client and FDA audits.
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Clinical Auditor/Qa Investigator/MicrobiologistTeva Pharmaceuticals Oct 1992 - Oct 1996
John Kohn Skills
Gcp
Pharmaceutical Industry
Clinical Trials
Sop
Fda
Vaccines
Ich Gcp
Quality Auditing
Quality Assurance
R&d
Validation
Clinical Research
Biotechnology
21 Cfr Part 11
Regulatory Affairs
Pharmacovigilance
Quality System
Gmp
Capa
Glp
Good Clinical Practice
Biopharmaceuticals
Standard Operating Procedure
Gxp
Computer System Validation
U.s. Food And Drug Administration
John Kohn Education Details
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Muhlenberg CollegeBiology And Natural Science -
Muhlenberg CollegeGeneral
Frequently Asked Questions about John Kohn
What company does John Kohn work for?
John Kohn works for Devpro Biopharma
What is John Kohn's role at the current company?
John Kohn's current role is Executive Director, Head of Quality Assurance at DevPro Biopharma.
What is John Kohn's email address?
John Kohn's email address is jo****@****eur.com
What is John Kohn's direct phone number?
John Kohn's direct phone number is +165030*****
What schools did John Kohn attend?
John Kohn attended Muhlenberg College, Muhlenberg College.
What skills is John Kohn known for?
John Kohn has skills like Gcp, Pharmaceutical Industry, Clinical Trials, Sop, Fda, Vaccines, Ich Gcp, Quality Auditing, Quality Assurance, R&d, Validation, Clinical Research.
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