David Oconnor

David Oconnor Email and Phone Number

Senior Director at Lachman Consultant Services
David Oconnor's Location
United States, United States
David Oconnor's Contact Details

David Oconnor personal email

n/a
About David Oconnor

Accomplished Quality Assurance professional with over 30 years of experience in pharmaceutical research from both a sponsor and Contract Research Organization (CRO) perspective for a multi-national company. Extensive QA experience in all aspects of Clinical (GCP) and Preclinical (GLP) studies and experience with Manufacturing (GMP) Quality Assurance responsibilities in R&D solid-dose formulations. Recognized leadership in the preparation, coordination and follow-up of regulatory inspections by US FDA, Health Canada, EMEA and ANVISA along with sponsor study and site qualification audits.Specialties: Data integrity, GLP and GCP compliance, bioanalytical analysis, bioequivalence and bioavaivability studies, Phase I-IV, negotiation skills

David Oconnor's Current Company Details

Senior Director at Lachman Consultant Services
David Oconnor Work Experience Details
  • Lachman Consultant Services
    Senior Director
    Lachman Consultant Services Feb 2022 - Sep 2024
    Westbury, Ny, Us
    I have decided to retire early to spend more time with family and friends. I have been so very fortunate to work with a great Team at Lachman Consultants for the past 11+ years helping our clients bring their lifesaving products to the global market. I am also very blessed for all the experiences gained from all my previous employers. I thank you all!!!
    View
  • Lachman Consultant Services
    Director
    Lachman Consultant Services Feb 2021 - Feb 2022
    Westbury, Ny, Us
    View
  • Lachman Consultant Services
    Associate Director
    Lachman Consultant Services Jan 2014 - Feb 2021
    Westbury, Ny, Us
    View
  • Lachman Consultant Services
    Senior Associate
    Lachman Consultant Services Apr 2013 - Dec 2013
    Westbury, Ny, Us
    View
  • Pracs Institute
    Sr. Director Quality Assurance - Bioanalytical
    Pracs Institute Aug 2012 - Mar 2013
    Fargo, Nd, Us
    Povide senior management leadership for quality activities across bioanalytical sites in the United States and Canada in support of sponsor’s drug development and regulatory submission activities. Coordinate, manage and follow-up sponor audits and regulatory inspections.
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  • Pracs Institute
    Sr. Director Quality Assurance - Bioanalytical
    Pracs Institute Aug 2009 - Jul 2012
    Fargo, Nd, Us
    Provide senior management leadership for quality activities across bioanalytical sites in the United States and Canada in support of sponsor’s drug development and regulatory submission activities. Coordinate, manage and follow-up regulatory inspections.
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  • Pracs Institute
    Qa Director
    Pracs Institute Oct 2005 - Jul 2009
    Fargo, Nd, Us
    Site lead of the Quality Assurance team to oversee quality of the bioanalytical operations to ensure that facilities, equipment, personnel, processes, methods and controls are in accordance with good regulated practices (GxP), company policies/procedures and study protocols.
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  • Apotex Inc.
    Qa Manager
    Apotex Inc. Nov 1998 - Oct 2005
    Toronto, Ontario, Ca
    Quality lead overseeing quality across clinical, bioanalytical and biometric operations to ensure that processes are implemented and respected in accordance with good regulated practices (GxP), company policies/procedures and study protocols. In addition, R&D Quality lead overseeing quality across R&D operations to ensure that processes are implemented in accordance with good regulated practices (GxP).
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  • Phoenix International Life Sciences
    Qa Manager
    Phoenix International Life Sciences Sep 1992 - Oct 1998
    Increasing QA resposibilities from Auditor to Head of the QA Unit. Responsible for assessing compliance to GLP/GCP regulations of the site through an extensive audit system. Oversee audits of pre-clinical, clinical, bioanalytical (HPLC, GC, LC-MS/MS, immunochemistry), PK and Clinical Investigation departments.

David Oconnor Skills

Fda Validation Cro Clinical Trials Gcp Glp Gmp Sop Quality Assurance Regulatory Submissions Gxp Drug Development Lifesciences Lims Clinical Development Bioanalysis Pharmaceutical Industry Hplc Good Laboratory Practice 21 Cfr Part 11 Regulatory Affairs Standard Operating Procedure U.s. Food And Drug Administration R&d Gas Chromatography Pharmaceutical Research Clinical Study Design Cro Management Good Clinical Practice Laboratory Information Management System Biotechnology Life Sciences Research And Development

David Oconnor Education Details

  • Mcgill University
    Mcgill University
    Chemistry

Frequently Asked Questions about David Oconnor

What is David Oconnor's role at the current company?

David Oconnor's current role is Senior Director at Lachman Consultant Services.

What is David Oconnor's email address?

David Oconnor's email address is da****@****ail.com

What schools did David Oconnor attend?

David Oconnor attended Mcgill University.

What skills is David Oconnor known for?

David Oconnor has skills like Fda, Validation, Cro, Clinical Trials, Gcp, Glp, Gmp, Sop, Quality Assurance, Regulatory Submissions, Gxp, Drug Development.

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