Immunomedics, Inc.

  • Director Clinical Quality Assurance

    Job Locations US-NJ-Morris Plains
    Posted Date 2 months ago(2 months ago)
    Job ID
    2018-1244
    # of Openings
    1
    Category
    Quality
  • Overview

    Director of GCP Quality Assurance will be responsible for managing and evaluating the compliance of clinical studies to FDA and International regulations and guidelines, as well as Immunomedics corporate policies and standard operating procedures. This role will focus on 1) managing internal audits 2) managing the GCP training program 3) assisting with inspection readiness 4) managing clinical records & documentation system 5) reviewing IND and NDA submissions 6) managing improvements on GCP processes 7) Ensuring compliant data integrity practices are followed.

    Responsibilities

       Establish the vision and implement the associated strategy for the GCP Quality Assurance function.

    ·       Ensure policies and/or procedures within clinical research, such as Clinical Development, Clinical Operations, Biostatistics, Pharmacology, Translational Medicine, Molecular Diagnostics and other departments, are adequate to achieve the goal of building quality within clinical research programs and activities, particularly focusing on a risk-based approach.

    ·       Develop, Implement and coordinate an effective GCP QA program and SOPs

    ·       Institute comprehensive GCP inspection readiness plans for regulatory authority inspections. Conduct the GCP inspections. Direct the development of adequate and appropriate responses and resolutions to identified observations. Drive timely completion of the agreed corrective and preventive actions.

    ·       Directs CQA Internal and external Audit Program for clinical investigator sites, external vendors, internal systems, key documents and reports. Establishes and maintains a schedule of audits. Establish effective means for communicating audit and inspection outcomes, developing metrics, measuring trends and driving improvements thus identified.

    ·       Proactively researches domestic and international GCP trends and initiatives to ensure compliance for internal and external services

    ·       Perform detailed review of policies, procedures, work instructions, clinical trial protocols, regulatory submissions, internal deviations, CAPAs and other essential documents prior to their Quality Assurance acceptance or approval.

    ·       Oversee company-wide required annual GCP training.

    ·       Monitor and reinforce timely completion of corrective and preventive actions that are defined to address GCP issues, regardless of the source.

    ·       Management of CQA Audit Management System

    ·       Establishes CQA training requirements, training programs and ensures compliance across the organization as well as ensuring appropriate training of personnel at participating clinical trial sites and CRO staff.

    ·       Responsible for setting CQA audit timelines and deliverables for assigned projects

    ·       Participates in the annual budgeting process

    ·       Establish the vision and implement the associated strategy for the GCP Quality Assurance function.

    ·       Ensure policies and/or procedures within clinical research, such as Clinical Development, Clinical Operations, Biostatistics, Pharmacology, Translational Medicine, Molecular Diagnostics and other departments, are adequate to achieve the goal of building quality within clinical research programs and activities, particularly focusing on a risk-based approach.

    ·       Develop, Implement and coordinate an effective GCP QA program and SOPs

    ·       Institute comprehensive GCP inspection readiness plans for regulatory authority inspections. Conduct the GCP inspections. Direct the development of adequate and appropriate responses and resolutions to identified observations. Drive timely completion of the agreed corrective and preventive actions.

    ·       Directs CQA Internal and external Audit Program for clinical investigator sites, external vendors, internal systems, key documents and reports. Establishes and maintains a schedule of audits. Establish effective means for communicating audit and inspection outcomes, developing metrics, measuring trends and driving improvements thus identified.

    ·       Proactively researches domestic and international GCP trends and initiatives to ensure compliance for internal and external services

    ·       Perform detailed review of policies, procedures, work instructions, clinical trial protocols, regulatory submissions, internal deviations, CAPAs and other essential documents prior to their Quality Assurance acceptance or approval.

    ·       Oversee company-wide required annual GCP training.

    ·       Monitor and reinforce timely completion of corrective and preventive actions that are defined to address GCP issues, regardless of the source.

    ·       Management of CQA Audit Management System

    ·       Establishes CQA training requirements, training programs and ensures compliance across the organization as well as ensuring appropriate training of personnel at participating clinical trial sites and CRO staff.

    ·       Responsible for setting CQA audit timelines and deliverables for assigned projects

    ·       Participates in the annual budgeting process

    ·       Participates in administration of comprehensive GCP training programs both internally and externally

    ·       Solves extremely complex and unique GCP problems to balance compliance and business needs

    ·       Presents GCP QA perspectives at investigator meetings and other internal functions

    ·       Ensures representation on appropriate clinical teams to facilitate audit planning and timely advice

    ·       Works closely with Regulatory, Clinical Operations,Clinical development, Data Management, Statistics, Safety and other development functional groups to establish quality standards and ensure adherence

    ·       Interacts with CROs, clinical investigators, contract labs and outside vendors, as needed

    ·       Partners with mid-level and senior management to assess needs, as requested

    ·       Ensuring clinical documentation and databases are compliant to GCP guidelines.

    ·       Work with Regulatory to ensure IND and NDA submissions documents meet GDP requirements.

    ·       Create report and track metrics for GCP QA functions.

    ·       Implement a continuous improvement GCP Quality culture and mindset.

    ·       Interact with the Pharmacovigilance, Pharmaceutical Development, and Operations functions on quality issues

    ·       Work closely with CMC Quality team to align Quality Culture across both CMC and Clinical organization.

    ·       Escalates critical quality problems to Senior Management in a timely manner.

    ·       Recruits, trains, develops, supports and motivates DC, QA and Validation personnel. Prepares, coordinates and schedules tasks, set goals and objectives for direct reports. 

    ·       Performs periodic evaluation of all direct reports.

    ·       Works within approved budget; conserves organizational resources.

    Qualifications

    • BS or MS is a relevant scientific discipline
    • At least 10 years of experience in GCP QA and Auditing
    • Solid understanding of the processes and interactions essential for successful GCP QA
    • Ability to prioritize and organize a high-volume workflow and follow a project through to completion
    • Highly collaborative person who can respond to constantly changing circumstances and needs
    • Solid experience reviewing GCPs, SOPs, audit procedures and reporting
    • Experience with inspection readiness through management of system audits and FDA inspections
    • Familiar with writing SOPs, reports and training materials
    • Knowledge of drug development, study design, data and trial management, procedures and documentation practices
    • Able to trouble-shoot complex GCP compliance issues and provide timely guidance for appropriate resolution
    • Capable of planning activities to meet department objectives
    • Working knowledge of GLPs
    • Experience with Phase IV After Market Clinical Studies and Pharmacovigilance (GPVPs)
    • 21 CFR Part 11 and Computer System Validation understanding

     

     

     

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