Immunomedics, Inc.

  • Senior Director, GxP Compliance - Biotechnology

    Job Locations US-NJ-Morris Plains
    Posted Date 2 months ago(7/5/2019 2:49 PM)
    Job ID
    2019-1442
    # of Openings
    1
    Category
    Quality
  • Overview

    The Senior Director, GxP Compliance will be responsible for the development, implementation, maintenance and continuous improvement of global Compliance programs to support Global GxP operations and supply within Immunomedics and ensure compliance with relevant regulations.

     

    Responsibilities

    Global Business Process and System owner for Compliance programs

    • Define and implement Compliance processes, procedures, tools and training to include internal auditing, Management Review, Quality Planning and Quality Risk Management.
    • Determine/implement IT solutions in support of processes
    • Understand and apply global regulations to processes to ensure compliance
    • Identify metrics for continuous improvement
    • Apply risk-based approach to process/systems
    • Understand and apply global regulations to processes to ensure compliance
    • Identify and manage resource needs to support growing organization and operational needs

     

     

    Oversees Quality Compliance group responsibilities

    • Ensure compliance across the organization by sustaining a level of inspection readiness by establishing and maintaining appropriate systems, processes, and procedures to meet regulatory requirements, guidelines and industry standards
    • Establish minimum requirements for Site Inspection Management Program
    • Maintain and deploy Inspection Risk Assessment Processes
    • Provide PAI and audit Training
    • Provide on-site Health Authority Inspection Support o Based on pre-defined criteria and site risk assessment
    • Generate the annual internal and external audit schedules in conjunction with functional peers
    • Perform vendor risk assessments to determine and evaluate audit frequency
    • Lead the internal audit program to ensure stakeholder system compliance with existing policies and procedures, and cGxP requirements, standards and guidelines
    • Ensure a constant state of inspection readiness
    • Develop and Manage the response process of Health Authority and Partner audit observations
    • Lead, facilitate and participate in Health Authority Inspections
    • Make recommendations to management regarding results of internal and external audits
    • Partner with local operational groups and network sites to foster a proactive approach to compliance
    • Provide QA advice to stakeholders (e.g., manufacturing, CROs, CMOs) based on analyses and interpretation of cGxP regulations
    • Establish and maintain cGxP compliance audit trends and metrics

     

     

    Key Relationships:

     

    Establish key stakeholder relationships with Quality, Operations, Regulatory, Supply Chain and Logistic partners. Able to interact with all levels within the organization.

     

    Qualifications

    Education: Relevant college or university degree required; advanced degree preferred.

     

    Experience: Minimum 15 years relevant work experience; Minimum 8 years of leadership experience including management of direct reports 

     

    Key Capabilities, Knowledge, and Skills:  

     

    • Understand GxP requirements for Compliance systems/processes in a Biotech organization focused on clinical and commercial operations in the United States, Europe, Asia and Japan.
    • IT system lifecycle knowledge to include requirements gathering, change management, implementation and continuous support
    • Experience in quality metrics reporting, analysis and process improvement techniques.
    • Knowledge of relevant GxP regulations and guidance to include but not limited to 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA.
    • Strong written and verbal communication skills, and analytical problem solving and conflict resolutions kills.
    • Flexible, highly motivated, with strong organization skills and the ability to multi task. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
    • Ability to work independently and to make decisions based on experience.
    • Effective interpersonal skills.

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