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Area Commercial Quality Manager, AFRICA

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Abbott Laboratories

23d ago

  • Job
    Full-time
    Senior Level
  • Healthcare
  • Johannesburg

AI generated summary

  • You need a Bachelor's in Pharmacy/Science/Engineering, 8+ years in Quality Assurance with 3+ years in a supervisory role, industry experience, strong skills, and English proficiency.
  • You will lead quality initiatives, manage complaints, oversee audits, ensure compliance, implement CAPA, and drive supplier qualification while fostering a quality culture across the organization.

Requirements

  • 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

Responsibilities

  • 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.

FAQs

What is the primary role of the Area Commercial Quality Manager for Africa?

The primary role is to provide strategic and operational quality leadership across the African continent, including managing quality oversight for third-party manufacturing in the region.

What qualifications are required for this position?

A Bachelor’s Degree in Pharmacy, Science, or Engineering is required, along with a minimum of 8 years in Quality Assurance/Compliance in a regulated industry, and at least 3 years in a supervisory or managerial role.

Is experience in the healthcare industry necessary for this job?

Yes, experience in the Medical Device, Pharmaceutical, In-Vitro Diagnostics, or Healthcare industry is essential.

What key responsibilities does the Area Commercial Quality Manager have regarding audits?

The manager is responsible for facilitating Corporate Quality Audits, Regulatory Audits, and ISO-Notified Body Audits, as well as representing the commercial quality team in internal compliance and third-party audits/inspections.

What skills are essential for success in this position?

Strong analytical, communication, decision-making, and leadership skills are essential. Additionally, the ability to manage multiple priorities and work effectively in a diverse, fast-paced environment is crucial.

Does this role require proficiency in any specific language?

Yes, proficiency in English, both verbal and written, is required. Experience with other African languages may be beneficial.

Will the Area Commercial Quality Manager be involved in complaint management?

Yes, the manager will handle quality complaints, ensuring timely investigation, resolution, and customer follow-ups.

What is the significance of the Quality Management System (QMS) in this role?

The QMS must be maintained and continually evaluated for suitability and adequacy in the commercial business to ensure compliance with Abbott’s Global Quality/Regulatory Framework and Divisional Policies.

Is previous experience in interacting with international teams a plus for this position?

Yes, having experience with other African countries would be beneficial for effectively managing quality across diverse regions.

What opportunities for professional growth are available in this role?

The position offers opportunities for professional growth and development within a global leader in healthcare, allowing individuals to make a significant impact on the quality and safety of healthcare products.

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Abbott Laboratories

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

At Abbott, we’re dedicated to helping people live more fully, in everything we do. We’re creating the future of healthcare through life-changing technologies that make you healthier and stronger, quickly identify when you have a medical need, and treat conditions to help you get back to doing what you love. With headquarters in north suburban Chicago, Abbott serves people in more than 160 countries with leading medical devices, diagnostics, nutrition products and branded generic medicines. More than 115,000 of us are helping millions of people to live better and healthier, every day around the world. Our employees do work that matters as part of a global community that supports them with career development opportunities and locally competitive benefits. Mission: We help people live better and healthier with our life-changing technologies. We're revolutionizing health with the most personal technologies, empowering people with the data and knowledge they need to help them live longer and better.