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Director Of Quality Assurance

Company: Cognate BioServices
Location: Memphis
Posted on: February 24, 2021

Job Description:

POSITION SUMMARY:

  • Responsible for working collaboratively with the Internal Teams to meet company and client goals
  • Build the Quality Assurance team, defining the organization's structure as well as managing a highly capable team of quality professionals with a clear vision to install quality processes, systems and relationships to drive best in class performance.
  • Familiarity with applicable regulatory requirements and compendia concerning GXP manufacturing in the Cell & Gene Therapy industries
  • Responsible for working collaboratively with the Internal Teams to meet company and client goals.
  • Quality Compliance including supplier quality, complaints, audits, and risk assessments
  • Quality Systems including document management, change control, CAPA and Nonconformances
  • Hires and develops employees within the department. Assigns work, provides feedback and coaching, and takes necessary disciplinary actions.
  • Coordinates and executes periodic Quality Management Reviews and trend analysis of all aspects of cGMP operations.
  • Analyzes regulatory authorities' programs, guidance documents and activities in areas relevant to testing of biological products and advises organization of potential actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
  • Manage audits and inspections by clients, FDA and other regulatory agencies as well as site regulatory inspection preparation and site internal audit program
  • Work with clients, external suppliers and contract labs to ensure compliance and quality, including management of audits and quality agreements
  • Identify and initiate improvements to the quality management system, ensuring compliance to all relevant quality standards and regulatory requirements
  • Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions to the adhered timelines as appropriate
  • Ensures the facility is in a constant state of inspection readiness across all functions through continuous education, training and internal audits.
  • Provide QA guidance to product development projects and technical transfer activities.
  • Supports quality assessments of internal operations to analyze compliance and assess risk.
    REQUIREMENTS:
    • BS required, MS preferred in a scientific/technical discipline with 12+ years of experience in a quality position within the biological and/or pharmaceutical industry.
    • 10+ years in a management/leadership role(s)
    • Excellent working knowledge and experience with the practical implementation of FDA and EMA regulations and guidelines in cGMP manufacturing operation. (21 CRF Part 11/210/211, 600, ATMP Annex 4, ICH 8, ICH 9, ICH 10).
    • Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy
    • Exceptional oral and written communication skills to all organization levels as well as clients and vendors
    • Extensive experience with managing regulatory inspections and client audits
    • Strong organizational skills; able to prioritize and manage through complex processes/projects
    • Ability to define problems, collect data, and draw valid conclusions
    • Experience in both startup/early phase and commercial GMP manufacturing organizations
    • Extensive experience with writing and managing investigations and risk assessments

Keywords: Cognate BioServices, Memphis , Director Of Quality Assurance, Executive , Memphis, Tennessee

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