Quality Assurance Manager
il y a 7 jours
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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