Immunomedics, Inc.

  • Manager, Deviation and CAPA

    Job Locations US-NJ-Morris Plains
    Posted Date 4 weeks ago(9/20/2018 10:46 AM)
    Job ID
    2018-1326
    # of Openings
    1
    Category
    Quality
  • Overview

    Ensure the deviation process meets Industry and Immunomedics expectations and requirements. Drives continuous improvement and enhancement efforts with regards to the management of Deviations to ensure an efficient yet Compliant process is maintained. Initiates, Reviews and Approves Deviations, OOSs, CAPAs, Quality Events to ensure adequate levels of documentation are adequate and compliant to existing procedures. Provides appropriate feedback as required. Performs CAPA effectiveness checks as required. Supports the coordination of activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to lead/facilitate investigations and to provide updates on discrepancy investigations; publish meeting minutes and action items from meetings; provide support to the investigation process and follow-up to ensure timely deviation closure. Initiates Escalation activities as required. Participate in escalation meetings as required. Performs trending analysis of deviations, CAPAs, OOS as required. Supports APQR program with regards to providing analysis for deviations and CAPAs. Supports the preparation and presentation of trend reports for Quality Management Reviews. Implements and ensures adherence of appropriate regulations and Immunomedics quality standards.

    Responsibilities

    • Lead deviation investigations.
    • Conducts timely information gathering sessions with Manufacturing, Laboratory or other personnel to obtain required information and data to complete an investigation.
    • Assess and document product impact and containment actions within the investigation
    • Lead team in conducting thorough root cause analysis and proper documentation within the investigation including causal factors identified and any root causes determined
    • Review and approve deviation and CAPA records, ensuring timely closure and adequate investigations have been performed to drill down to root cause.
    • Based on root cause outcome, ensure proper identification and initiation of corrective actions (CAPAs)
    • Ensure that complete accurate and thorough historical searches within deviation database are performed to identify any similar events and determine if a trend exists or is developing.
    • Own CAPA system and provide project management oversight of the CAPAs to ensure all required corrective actions remain on track and are closed by assigned due dates.
    • Lead process improvements associated with investigation processes.
    • Lead weekly deviation review board meetings to assess criticality of deviations and identify corrective and preventative actions.
    • Keep metrics on status of deviations and CAPAs
    • Lead cross-functional team deviations
    • Performs trending analysis of deviations, CAPAs, OOS as required.
    • Supports APQR program with regards to providing analysis for deviations and CAPAs.
    • Other duties may be assigned
    • Carries out direct supervisory responsibilities in accordance with the department-set goals.   Responsibilities include interviewing and onboarding; employee training and development; planning, assigning, and directing work; appraising performance; rewarding and disciplining; corrective action and complaint resolution

    Qualifications

    • BS/BA in Biological Sciences or equivalent relevant career experience Fluent in speaking/writing English.
    • Minimum of 7 years GMP manufacturing and/or QA related experience, at least 2 years of which are in the area of quality assurance and/or compliance or equivalent experience.
    • Experience in working in Development, Commercial and/or Quality Control functions is desired.
    • Excellent written and verbal communication skills required, including Responsible Business Communication.
    • Scientific writing experience preferred.
    • Superior attention to detail, and the ability to handle multiple tasks in a timeline-driven environment necessary.
    • Strong customer service philosophy required; experience a plus.
    • Must be proficient with MS Office applications.
    • Strong planning, execution, interpersonal, communication, negotiation and problem-solving skills
    • Strong project management skills
    • Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally

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