Area Commercial Quality Manager, AFRICA

at  Abbott Laboratories

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. For more information on ARDx, please visit www.alere.com.

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

• 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.