Joe Quick Email & Phone Number

United States

Compliance Manager for autoinjector products• Manage team responsible for consistent, disciplined execution of CAPAs/investigations using six sigma tools to achieve root cause • Manage team responsible to track and complete CAPAs assigned to combo product assembly and packaging operations• Lead teams to improve automated, semi-automated and manual visual inspection processes• Interact with FDA and EU inspectors during inspections

United States

• Manage projects bringing new equipment/products online at the facility• Interact with R&D to assess feasibility and regulatory requirements• Assess validation requirements and approve protocols for new equipment and operating lines• Use Operational Excellence tools such as, Six Sigma, lean Leader and 5S to streamline processes and reduce waste and improve compliance• Interact with FDA and EU inspectors during inspections

United States

• Manage a multiple shift, fast paced QA operations group responsible for QA oversight of aseptic, terminally sterilized and oral dose manufacturing and the disposition of raw materials, packaging materials, components and final product. Reduced product release cycle times by >30%• Manage the Quality Investigations Group responsible for overseeing and approving exceptions/deviations using cross functional teams and investigation tools for example, Fishbone, 5 why and Kepner Tregoe. Increased quality of investigations focusing on root cause, corrective/preventative action while decreasing cycle time to closure and reducing ov• Responsible for the review of change controls and documents that affect QA and Manufacturing• Managed the Label Control group responsible for all regulated label and packaging changes to comply with multiple countries• Host and interact with regulatory inspectors during audits

United States

• Overall responsible for the Rockville GMP Facility Quality Assurance including product disposition and oversight of QC• Responsible for the development, implementation, and maintenance of quality systems• Coordinate approved vendor program and aid in qualifying vendors and contractors• Responsible for the management of facility, equipment and process validation programs• Responsible for developing and managing the Quality Assurance budget