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Quality Assurance Lead - Quality Systems

Company: Uniqure NV
Location: Lexington
Posted on: April 10, 2021

Job Description:

Quality Assurance Lead - Quality Systems -- Location: -- Lexington, Massachusetts (US) Education level: Bachelor / Graduate-- -- Job category: -- Quality Assurance Target start date: 4/19/2021 uniQure is dedicated to bringing innovative therapies of unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need. The Quality Assurance Lead supports the day-to-day quality operations via oversight of all elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, excursions, Out of Specifications (OOS), change control, batch review and disposition, and data integrity in support of biologics manufacturing production. Additional responsibilities include supporting/conducting internal audits and external supplier/vendor audits. Key result areas (major duties, accountabilities and responsibilities)

  • Support cGMP manufacturing operations through administration and enforcement of the Quality Management System including, but not limited to, deviations, change controls, and CAPAs.
  • Responsible for tracking and trending QMS metrics including, but not limited to, those related to deviations, CAPA, Change Controls, OOS, and internal/external audits performance.
  • Compile metrics for monthly operations reports.
  • Support the supplier quality program through review and approval of vendor change notifications, part number requests, raw material specifications, and raw material release.
  • Conduct/assist in internal audits and in external supplier/vendor audits against applicable quality system standards and regulations.
  • Represent Quality Assurance on project teams and in meetings.
  • Support the continuous improvement and oversight of Quality Management System procedures. Qualifications
    • A minimum of a Bachelor's degree in Life Sciences or Engineering
    • 6-8 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
    • Well versed in cGMP/ICH/FDA/EU regulations and guidelines
    • Proficient in using Microsoft applications (MS Word, MS Excel, MS Powerpoint)
    • Internal and/or External audit experience preferred
    • 20-40% travel may be required Core competencies
      • Strong organizational skill
      • Capable of working with minimal supervision
      • Ability to work well with diverse groups
      • Ability to manage multiple activities with challenging timelines

Keywords: Uniqure NV, Huntsville , Quality Assurance Lead - Quality Systems, Other , Lexington, Alabama

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