Agenus

QA Manager

US-MA-Lexington
Job ID
2017-1276
Category
Quality

Overview

Provide daily operational support for all Quality functions including documentation control, issuance and tracking of OOS, Deviation, MRB, EMIs, etc., provide GMP and core competency training, review of quality data (validation, stability, batch analysis, environmental, etc.) and disposition of raw materials, intermediates and final product.  Assures that the Equipment Calibration Program and validation complies with the GMPs requirements.  Coordinates interdepartmental activities.   

The QA Manager, Compliance and Documentation is responsible for providing cGMP compliance and documentation support to the site operations in Lexington, MA. The compliance and documentation team manages and supports to create, review and approve documentation, including standard operating procedures, protocols and reports.  This role drives manufacturing compliance to meet various regulatory requirements and quality systems in a GMP environment. The compliance and documentation team will manage deviations, CAPAs and change controls with the support of appropriate personnel.  This role also responsible for continual monitoring of quality indicators; trending, tracking and metrics reporting, and escalation, as appropriate.

Responsibilities

  • Required Tasks
    • Issuance and tracking of Quality Management System (Change Control, OOS, Deviation, etc.)
    • Operational support for all Quality functions
    • Manage QA budgets as needed
    • Participate in various department initiatives and projects as needed and appropriate
  • Responsibilities
    • Supervision and management of QA staff
    • Act as back-up to Quality Assurance Senior Management
  • Implement, manage strong GMP systems for manufacturing operations meeting all quality requirements
  • Manage document creation and revision process within Master Control (EDMS system). Documents to include SOPs, master batch records, appropriate validation, technical reports, protocols.
  • Provides support to author and review for both clinical and commercial filings, as needed basis.
  • Works with GMP partnering departments, develops training requirements and ensures GMP compliance to manufacturing organization, including adherence to all training requirements.
    • Assist in the development of and lead the implementation of Global Quality System within Agenus Lexington facility
    • Lead risk assessment discussions to define, document and integrate risk management into day to day activities
    • Evaluate, schedule, and balance departmental workload with respect to assignments/ responsibilities/personnel, interviewing, hiring, training, and mentoring of subordinate employees
    • Partner with QA Senior Management and Lexington site to lead and manage key departmental improvement project and initiatives
  • Ensures timely completion of deviations, CAPAs, and change controls.
  • Build, develop and lead a high performing Documentation and Compliance team to support the GMP manufacturing facilities in Lexington
    • Tracks all manufacturing personnel including contractors, consultants and temporary employees have the necessary qualifications and training to perform their job in accordance with applicable procedures and regulations
  • Provide excellent customer service and create strong partnerships with internal and external partners including Quality Assurance, Manufacturing, Process Sciences, Quality Control and Validation
  • Duties
    • Management of Electronic Documentation Control system (Master Control)
    • Conduct Quality trainings for department and other functional areas
    • Review of quality data
    • Lead trending and KPI data gathering, evaluation and reporting for site management reviews
  • Specific skills relevant to the job
    • Must be hands-on, self motivated and very detail oriented
    • Supervisory experience
    • Knowledge of quality systems and global cGMP regulations
    • Knowledge of document control and records management using electronic system
    • Must have excellent interpersonal and customer service skills.

Qualifications

  • BA or BS in a scientific or related field
  • 3+ years supervising direct reports
  • At least 8 years’ experience in a GMP Facilities environment within the biotech or pharmaceutical industries

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