Commercial Quality Manager for Africa

1 month ago


Johannesburg, Gauteng, South Africa Abbott Full time
Africa Commercial Quality Leadership Opportunity

This role serves as the Commercial Quality Area Manager for the African continent, providing strategic & operational quality leadership across the region. The position manages quality oversight for third-party manufacturing within the region.

Key Responsibilities:
  • Ensure compliance with Abbott's Global Quality/Regulatory Framework and Divisional Policies.
  • Foster a quality culture across people, processes, products, and services to meet customer needs.
  • Maintain and continually evaluate the QMS for suitability and adequacy in the commercial business.
  • Represent commercial leaders in quality decisions, including escalations, field actions, and significant quality issues.
  • Handle quality complaints, ensuring timely investigation, resolution, and customer follow-ups.
  • Collaborate globally to fulfill Field Corrective Actions from Regulatory Field Safety Notifications.
  • Provide quality support for post-market surveillance activities to minimize product supply interruptions.
  • Facilitate Corporate Quality Audits, Regulatory Audits, and ISO-Notified Body Audits.
  • Implement effective CAPA Program across the operational site.
  • Drive the Supplier Qualification Program, including identification, evaluation, monitoring, maintenance, and re-qualification.
  • Oversee the Quality Control program for imported products, ensuring compliance and timely product release.
  • Ensure continuous compliance with Abbott quality standards and regulatory requirements.
  • Manage and resolve product issues promptly, coordinating cross-functionally as needed.
  • Track, trend, and report site Quality metrics to ensure key performance indicators are met.
Qualifications:
  • Bachelor's Degree in Pharmacy, Science, or Engineering.
  • Minimum of 8 years in Quality Assurance/Compliance in a regulated industry, with at least 3 years in a supervisory/managerial role.
  • Experience in the Medical Device, Pharmaceutical, In-Vitro Diagnostics, or Healthcare industry.
  • Strong analytical, communication, decision-making, and leadership skills.
  • Proficiency in English, both verbal and written.
Estimated Salary: $80,000 - $120,000 per year

Based on location and experience, this role offers a competitive salary package with opportunities for growth and development.



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