• Site Director, Quality

    Job Locations US-CA-Seal Beach
    Job ID
    2018-1368
    Category
    Quality Assurance
  • Overview

    This position is responsible and accountable for the execution of all activities associated with the Quality Unit (Quality Assurance and Quality Control) at either of the Immunotherapy Manufacturing Facilities (IMF) to ensure patient safety. The role ensures the site, process, product, and personnel are compliant with all applicable regulatory requirements. It is a key partner to all Executive Quality and Operations Leadership to ensure FDA readiness. This role is a key strategic quality leader and needs substantial experience in GMP operations, regulatory inspections, internal and external audit, and excellent verbal and written communication skills.

    Responsibilities

    Responsibilities:

    • Participates in developing company Quality strategic plans and objectives.
    • Maintains compliance and inspection readiness for the Site.
    • Facilitates Quality Improvement activities related to compliance, cost and cycle time
    • Drives risk analysis and develops solutions to a variety of complex problems.
    • Partners with IMF site leaders to deliver efficient and effective Quality function performance at the IMF.

     

    Scope:

    Directs overall operational leadership in planning and management of quality systems and activities, including resource management and vendor management, which includes the following:

     

    • Corrective and preventive action program
    • Change control
    • Document control
    • Validation program
    • GMP material review and disposition
    • Internal and external quality audits
    • Pre- and post-approval compliance audit preparation
    • GMP training program
    • Quality engineering (optional)
    • Supply Quality Management/Compliance (optional)


    Implements corporate Quality policies ensuring
    finished products conform to company standards and satisfy GMP regulations.

    • Oversees project risk analysis and develop solutions to a variety of complex problems.
    • Collaborates with other departments during planning and process improvement activities to ensure timely completion of all operational areas objectives and milestones.
    • Participates in steering committees that set general business corporate policy and sponsor corporate programs.
    • Interfaces with external customers and FDA during audits and inspections.
    • Mentors and develops department personnel, including supervisory / management staff.
    • Defines framework for department objectives, operation schedule, processes and budgets.

    Contributes to Quality department strategic management.

    Qualifications

    Job Requirements:

    • Bachelor’s degree in a scientific discipline or equivalent.
    • 10 years related experience in cGMP/FDA regulated industry.
    • 5 years of experience managing supervisory personnel and contributing toward the development of department strategy.
    • Knowledge of cGMP/QSR and FDA device/drug/biologics regulations.
    • Experience in developing and making formal presentations to executive management.
    • Experience with department budget planning, management and reconciliation.
    • Experience with ERP systems preferred.
    • 10-15% travel

     

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