John Kohn Email & Phone Number

Basking Ridge, Nj, Us

General 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.).

Bedminster, New Jersey, Us

Manage 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

Provide 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

Paris, France, Fr

Provides 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.

Paris, France, Fr

Provide 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

Provide 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.

King Of Prussia, Pennsylvania, Us

Performed 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

Perform 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.

Bachelor Of Science (Bs), Biology And Natural Science

Bachelor Of Science (Bs), Biology, General