JOB DESCRIPTION: DO WORK THAT MATTERS.At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.Abbott Rapid Diagnostics (ARDx) is a sub-division of Abbott Diagnostics, created from the acquisition of Alere.ARDx believes that when diagnosing and monitoring health conditions, knowing now matters. ARDx delivers on this vision by providing reliable and actionable information through rapid diagnostic tests, enhancing clinical and economic health outcomes globally. ARDx focuses on rapid diagnostics for infectious disease, cardio-metabolic disease and toxicology.The OpportunityThis role will serve as the Commercial Quality Area Manager for the African continent, providing strategic & operational quality leadership across the region. The position will also manage quality oversight for third-party manufacturing within the region.WHAT WILL YOU DO?Quality Leadership: Act as the Management Representative for Quality and Regulatory requirements, ensuring compliance with Abbott's Global Quality/Regulatory Framework and Divisional Policies.Quality Culture: Proactively foster a quality culture across people, processes, products, and services to meet customer needs.Quality Management System (QMS): Maintain and continually evaluate the QMS for suitability and adequacy in the commercial business.Decision Making: Represent commercial leaders in quality decisions, including escalations, field actions, and significant quality issues.Complaint Management: Handle quality complaints, ensuring timely investigation, resolution, and customer follow-ups.Field Corrective Actions: Collaborate globally to fulfill Field Corrective Actions from Regulatory Field Safety Notifications.Post Market Surveillance: Provide quality support for post-market surveillance activities to minimize product supply interruptions.Audits: Facilitate Corporate Quality Audits, Regulatory Audits, and ISO-Notified Body Audits.CAPA Program: Implement effective Corrective and Preventive Actions (CAPA) across the operational site.Supplier Qualification: Drive the Supplier Qualification Program, including identification, evaluation, monitoring, maintenance, and re-qualification.Quality Control: Oversee the Quality Control program for imported products, ensuring compliance and timely product release.Compliance: Ensure continuous compliance with Abbott quality standards and regulatory requirements.Issue Resolution: Manage and resolve product issues promptly, coordinating cross-functionally as needed.Quality Metrics: Track, trend, and report site Quality metrics to ensure key performance indicators are met.Audit Coordination: Represent the commercial quality team in internal compliance and third-party audits/inspections.Qualifications:Education: Bachelor's Degree in Pharmacy, Science, or Engineering.Experience: Minimum of 8 years in Quality Assurance/Compliance in a regulated industry, with at least 3 years in a supervisory/managerial role is ESSENTIAL.Industry Knowledge: Experience in the Medical Device, Pharmaceutical, In-Vitro Diagnostics, or Healthcare industry.Skills: Strong analytical, communication, decision-making, and leadership skills. Ability to manage multiple priorities and work effectively in a diverse, fast-paced environment.Language: Proficiency in English, both verbal and written.Experience with other AFRICAN countries would be beneficial.Competencies:Strong negotiation skills and the ability to interact with external and internal customers and partners.Superior attention to detail and accuracy.Ability to overcome cultural and language barriers to provide effective solutions.Experience in conducting and handling audits and inspections.Why Join Us?Be part of a global leader in healthcare.Work in a collaborative and innovative environment.Opportunities for professional growth and development.Make a significant impact on the quality and safety of healthcare products.The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted.JOB FAMILY: Operations Quality DIVISION: ID Infectious Disease LOCATION: South Africa > Johannesburg : Abbott Place ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Not Applicable
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