• Director/Sr. Director, Quality Control

    Job Locations US-MA-Bedford
    Posted Date 2 weeks ago(6/1/2018 8:42 AM)
    Job ID
    2018-1074
    # of Openings
    1
    Category
    Quality
  • Overview

    Direct the development, planning, implementation, and maintenance of Quality methods, processes, and operations for new or existing products and/or technologies.  The QC group is comprised of the following functions: Analytical Chemistry, Microbiology, Environmental Monitoring, QC inspection, QC data management and support.  Provide strategic and tactical leadership to the Quality organization ensuring the execution of responsibilities within the Quality System. Responsible for all work completed within the QC group for pharmaceutical and medical device products. 

    Responsibilities

    • Provide strategic and tactical leadership for the Quality Control function through development and implementation of the overall quality control plan. Mentor and assist team members with personal and professional development.
    • Direct the development, planning, implementation, and maintenance of QC test methods, processes and operations.
    • Ensure quality control laboratories are maintained per internal procedures and industry standards.
    • Build in-house capabilities as required to ensure regulatory compliance and functional goals in support of clinical studies and commercialization.
    • Manage internal and external cGMP laboratories by reviewing and approving documents as required, including SOPs, protocols, reports, test methods, change requests, technical transfers, OOS investigations, and deviation investigations.
    • Ensures that critical raw material, in-process and final release testing is accurate and reported to meet timelines.
    • Determine and implement sterility and biological test/validation requirements utilizing appropriate industry standards for new products.
    • Provide oversight to product stability program and establish product life.
    • Develop and implement procedures for analytical method transfers and qualification/validation. Work closely with Assay Development and Quality Assurance functions to establish method transfer/qualification criteria. 
    • Assist in preparation of CMC sections of regulatory submissions as requested.
    • Interface with R&D to ensure that project teams are designing for patient safety (relating to FMEA and Hazard Analysis), Quality Systems compliance, and manufacturability in the development phases of the project.
    • Develop, refine, and document quality control test and inspection procedures.
    • Track and trend cGMP data including the evaluation and approval of data received from external contract laboratories. Compile and report data with appropriate interpretations for internal Management Reviews, Annual Product Reviews, and all other required assessments.
    • Other duties as assigned

               

    Supervisory Responsibilities:

     

    • May supervise Quality Analytical Chemists, Quality Control Inspectors, and Environmental Monitoring group

    Qualifications

    • Bachelor’s Degree in a scientific/engineering discipline required; advanced degree preferred.
    • Must have a minimum of 10 years of experience in a pharmaceutical quality control role (CMC, Phase 1-3 clinical development); 5 years in a management position.
    • Must have experience with USP/EP compendia, cGMP, GLP, and ICH guidelines and documentation requirements
    • Must be knowledgeable in the application of quality principals and industry guidelines for Quality Systems
    • Must be able to advise and/or teach others on the quality requirements of the company, including products, customer requirements and the interpretation of various industry guidelines
    • Demonstrated operational excellence of laboratories
    • Must have strong hands-on leadership and communication skills
    • Must be able to conduct an audit; must be able to be audited. Must be familiar with statistical principles as they relate to statistical sampling plans

     

    Working Conditions

     

    • Minimal travel
    • Ability to gown and gain entry to manufacturing areas

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