Immunomedics, Inc.

  • Associate Director, Quality Systems

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(4/18/2019 7:57 PM)
    Job ID
    2019-1438
    # of Openings
    1
    Category
    Quality
  • Overview

    Associate Director of Quality Systems provides oversight to Quality Systems such as change control process, document control / management, Risk Management and, Computer System Validation (CSV), and general QA Validation oversight. Quality System group will also manage Quality System updates and provide day to day management to these Quality Systems. QA System group will provide trending for Quality Systems. This position may also be cross trained to cover other QA functions as needed.

    Responsibilities

    Responsibilities:

    • Provides leadership to employees in the identified areas concerning GMP compliance.
    • Assists with preparation for FDA and other regulatory agency audits and inspections.
      Understands practical applications of GMP phased approach and a Risk based Quality approach. Writes and updates existing procedural documents to incorporate these approaches.

      Reviews Calibration and Preventive Maintenance Records.
    • Provides QA Oversight for Life Cycle Validation process executed for system, processes, method, equipment and others.
    • Prioritizes work in alignment with company priorities.
    • Develops goals and objectives for the department in alignment with corporate goals and objectives.
    • Helps develop annual budget for QA department at the Judicial Site
      Maintains Good Manufacturing Practice (GMP) at company.
    • Gives guidance and support to R&D, Tech Ops and other departments on data integrity and Good Documentation Practices.
    • Understands practical applications of GMP phased approach and a Risk based Quality approach. Writes and updates existing procedural documents to incorporate these approaches.
    • Prioritizes work in alignment with company priorities.
    • Develops goals and objectives for the department in alignment with corporate goals and objectives.
    • Helps develop annual budget for QA department at the Judicial Site.
      Assists with Document Control and other QA functions.
    • Maintains Good Manufacturing Practice (GMP) at company.
    • Carries out direct supervisory responsibilities in accordance with the department-set goals.   Responsibilities include interviewing potential employees; employee training and development; planning, assigning, and directing work; appraising performance; rewarding and disciplining; corrective action and complaint resolution.

    Qualifications

     

    • BS in Life Sciences or equivalent with 10+ years related experience within a pharmaceutical or Biotechnology Company.
    • QA Management and hands-on QA Systems experience including supporting Validations within pharmaceutical or Biotechnology Company.
    • At least Four (4) years supervisory experience.
    • Must be fluent in English language.
    • Additional technical experience in an area allied with cGMP Quality, Biopharma Production Processes, 21CFR 210-211, ICH guidelines, FDA Guidance for Industry for Investigating OOS Results, Deviations, CAPAs, Validation, Stability Studies, QC laboratory operations and manufacturing operations, auditing is preferred.
    • QA Management and hands-on QA Operations and QA Systems experience including supporting Validations within pharmaceutical or Biotechnology Company. At least Six (6) years supervisory experience.

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