Immunomedics, Inc.

  • Manager, CMO Quality

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(4/16/2019 8:45 AM)
    Job ID
    2019-1434
    # of Openings
    1
    Category
    Quality
  • Overview

    The Manager, CMO - Quality Assurance is responsible for managing activities within Quality Assurance for all CMO (Contract Manufacturing Operations). This position also contributes to the completion of routine technical tasks and any additional quality task identified.

    Responsibilities

    Key Responsibilities:

     

    • Ensure financial prudence in resource planning, allocation, and manage within approved budgets while building best in class quality processes and systems at site.
    • Maintain quality system controls to ensure no critical and major market complaints.
    • Take appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency

     

    Quality Support:

     

    • Write, manage, and periodically review all Quality Management System (QMS) activities in coordination with Operations
    • Ensure all required Manufacturing Site, External Testing and FDA required documentation is current and inspection ready for Operations
    • Provide support for reviewing any required technical documents for Operations
    • Provide required support during FDA Inspections on behalf of the company

    Contract Manufacturing (CMO) Support:

     

    • Perform external Inspections/Monitoring of Projects performed at Contract Manufacturers (CMO) on behalf of the company.
    • Oversee the compliance performance of CMOs sourcing product to the company
    • Managing Quality Agreements for all CMOs
    • Perform QA Technical Document Reviews supporting technical transfers and validations for new products at CMOs
    • Provide QA support with related to Quality Complaints and CAPA for all CMO related operations.
    • Provide QA management with metrics regarding CMO-based deliverables and commitments.
    • Performs routine CMO performance.
    • Establishes good working relations with Contract Manufacturers.
    • Supports in the development of methods transfer and validation, troubleshooting, cross validation, IQ/OQ protocols.
    • Supports activities regarding audits of suppliers and contract labs in support of vendor certification program.
    • Ensure that all US-CMO are Inspection Ready.

     

    Qualifications

    Education:

    • Bachelor’s/ Master’s degree in Life Sciences, pharmaceuticals, engineering field, or closely related scientific disciplines

    Experience:

    • Minimum of 4+ years’ experience in Manufacturing, Quality, Analytical or Sterile Manufacturing areas
    • Understanding of cGMPs, FDA, DEA regulations
    • Strong technical writing skills required.
    • ISO and/or CQA certifications preferable

    Skills:

    • Must be proactive and results oriented, with a strong attention to detail.
    • Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.
    • Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment.
    • Strong organizational, analytical, troubleshooting and problem-solving skills. Ability to analyze details and perform structured decision-making on a daily basis.
    • Excellent verbal and written communication. Must be able to read, write, and speak English.
    • Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
    • Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc. Knowledge of LIMS (Laboratory Information Management System) is a plus.
    • Good communications skills, self-starter, ability to train
    • Will be an added advantage if the individual has worked in Regulatory/GMP environments or sterile manufacturing.

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