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Senior Manager of Quality Assurance
Ref No.: 17-00293
Category: Biotechnology
Location: Doylestown, Pennsylvania
Basic Purpose and Objective: The Senior Manager of Quality Assurance position is an integral team member role and is directly responsible for the overall supervision and management of a quality management system that is maintained throughout the entire company. The position will be responsible for the maintenance of the company's GxP quality and compliance program and oversee personnel accountability for the company's GxP procedures.

Job Responsibilities:
  • Maintain a quality management system that complies with GxP practices.
  • Manage internal auditing program including planning, conduct, and reporting of audits.
  • Perform internal audits to assure compliance with policies, procedures, and applicable regulatory requirements.
  • Create reports on the performance of the quality system.
  • Maintain the master schedule.
  • Maintain training records and create new training forms as necessary.
  • Act as an independent reviewer of data, processes, and documentation.
  • In conjunction with Business Development and Operations, host client audit visits, and prepare documentation as needed prior to, during and after audits to ensure client expectations are met.
  • Manage document control.
  • Report on the outcome of regulatory inspections, client audits, and internal facility inspections, in writing, to management.
  • Track vendor quality assessments.
  • Responsible for management of SOPs including review, periodic review and implementation of SOPs as required.
  • Act as SOP Coordinator to track version changes of SOPs and distribution and training of new SOP versions.
  • Performs any other duties as required or assigned.

Requirements:
  • Minimum of Bachelor or Masters of Science or Arts degree in a scientifically related discipline with at least 10 years of prior industry experience in both scientific and quality assurance related positions.
  • Experience in a GxP laboratory environment required. Experience in a CRO or pharmaceutical company.
  • Outstanding communication skills (including written and verbal) with ability to communicate at all levels.
  • Ability to manage through change and work in an innovative, fast-paced environment.
  • Detail oriented while able to manage multiple products simultaneously, and strong problem solving skills with a proactive approach are key skill sets.

Dana Zurawski

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201-986-7888