Quality Assurance Manager

il y a 7 jours


Rungis, Île-de-France Abbott Temps plein

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

Main Responsibilities:

  • Maintain the Quality Management System at Commercial Affiliate level, ensuring compliance with regulatory requirements.
  • Plan and conduct internal audits to verify the effectiveness of the management system, identifying areas for improvement.
  • Prepare and coordinate external audits, ensuring timely completion and resolution of any issues.
  • Support and provide training to the Commercial organization on quality management systems and regulatory compliance.
  • Ensure Quality System record keeping, document control, Warehousing, Quality Holds, Supplier/Distributor evaluation/monitoring, CAPA management follow-up, and timely closure.
  • Coordinate Field Communications at the Region, ensuring effective communication with stakeholders.
  • Ensure availability of org charts and job descriptions, maintaining up-to-date documentation.
  • Assess risk related to processes, identifying potential areas for improvement.
  • Timely escalate regional concerns to Area Management Review, ensuring prompt resolution.
  • Support Global Commercial Affiliates Quality improvement projects, driving quality excellence.
  • Coordinate communication between commercial organization and Regulatory to support responses in contracts and public tenders.
  • Be the expert on a Quality System process, supporting the rest of the team in quality-related matters.
  • Review Abbott policies & procedures, and update Quality documentation accordingly, ensuring compliance with regulatory requirements.
  • Participate in Quality System improvements and implementation projects, driving quality excellence.
  • Actively seek internal/external customer feedback and respond to issues, ensuring customer satisfaction.
  • Ensure revision and approval of locally/translated Promotional material, maintaining regulatory compliance.
  • Act as an expert for sales and customer support for accreditation topics, presentations, and process implementation in sites where customer certification/accreditation is requested.

Background:

  • University degree in science, engineering, pharmaceutical, etc.
  • Fluent in French and good command of English.
  • Quality Assurance in a Commercial Affiliate environment needed.
  • Experience as a quality specialist or manager.
  • Management skills and leadership competencies.

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