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Director, Quality Assurance

Company: AGTC
Location: Gainesville
Posted on: February 11, 2020

Job Description:

Mission The Director, Quality Assurance is an influential hands-on leader of quality operations and quality management systems for AGTC. Reporting Relationship

  • The Director, Quality Assurance reports directly to the Executive Director, Regulatory Affairs.
  • Quality Assurance and Quality Control personnel report to the Director, Quality Assurance. Essential Duties and Responsibilities
    • Develop and improve quality systems, programs and procedures to promote, facilitate, and ensure compliance with domestic and international regulatory and industry standards and implement risk-based methodologies to improve efficiencies.
    • Institute key quality processes, metrics and indicators to measure, trend and improve quality determinants of all aspects of GLP, GMP and GCP.
    • Direct Quality Control activities for the collection, review and maintenance of product testing documentation.
    • Provide leadership for vendor identification, evaluation and management activities.
    • Facilitate the authoring and implementation of Quality SOPs and the management of SOPs for other functional groups within AGTC.
    • Facilitate the review and approval of study protocols, study reports, batch production records and other controlled documents.
    • Provide or facilitate GxP training of AGTC staff while developing and maintaining a training documentation system.
    • Work closely with Operations, Finance, and R&D to promote effective teamwork and work proactively and collaboratively to provide prompt solutions and improved processes designed to address compliance concerns.
    • Communicate an engaging quality mission to each key functional area to inspire proactive attention to this critical area within AGTC.
    • Maintain active involvement in biotechnology and Quality Assurance organizations to ensure up-to-date knowledge of current and future industry trends related to FDA, ICH and GxP regulations and guidelines.
    • Provide technical leadership and vision by interpreting regulatory compliance initiatives and mandates, while uncovering emerging trends regarding future regulation of drugs and biologics.
    • Instill discipline and process to the company's quality efforts to ensure the highest level of quality throughout AGTC, while participating in the preparation of an overall expense budget and any necessary headcount forecast for the Quality department.
    • Attract, train, develop and mentor the very highest caliber of quality employees. Develop staffing requirements and assume responsibility for planning, recruiting, training and motivating any necessary additional team members.
    • Other duties as assigned Educational Qualifications
      • Bachelor's degree required, preferably in the life sciences, engineering or related fields
      • Advanced degree advantageous and ASQ CQE and CQA Certifications are preferred. Additional Qualifications
        • Eight (8) or more years of progressive Quality Assurance experience within the life science industry, and preferably within the biotechnology or pharmaceutical industries specifically.
        • Previous experience within smaller, more entrepreneurial drug development companies will be considered beneficial.
        • Must have in-depth understanding of GLP, GMP and GCP processes and procedures.
        • Strong business acumen to ensure AGTC's ability to meet regulations and strategic objectives; and a history of leadership, change management, clear communication, analytical thinking, organization, and implementation skills should be evident in his/her background. Physical Requirements
          • Physical demands: --- sedentary ( --- light work ( --- medium work ( --- heavy work ( --- very heavy work (> 100 lbs.)
            • Physical activity: --- repetitive motion --- balancing ---stooping ---lifting ---climbing ---kneeling/crouching ---crawling ---reaching ---standing--- typing/grasping --- walking ---pushing/pulling --- hearing
              • Visual acuity: reading, writing
              • Working conditions: indoor Supervisory Responsibilities
                • Previous management or supervisory experience required
                • Will have supervisory responsibility for Quality Assurance and Quality Control personnel
                • One-on-one meetings with the direct supervisor will be conducted weekly for the review of progress on work plans and data analysis. Measures of Performance
                  • An initial Performance Review will be completed three (3) months from the hiring date.
                  • Subsequent Performance Reviews will be conducted annually within 60 days of the Company's fiscal year end.
                  • Weekly one-on-one meetings with the Executive Director, Regulatory Affairs will be conducted for review of work plans and data analysis.

Keywords: AGTC, Gainesville , Director, Quality Assurance, Executive , Gainesville, Florida

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