Quality Assurance Manager at Abbott

Primary Objective

• The Quality Manager South Africa represents the main interface between Molecular Diagnostics Quality Assurance Division, Commercial and Service & Support Leaders in South Africa responsible to assure full compliance to all Quality related processes and procedures including managing quality activities at local warehouses, spare part depots and distribution centers.
• Ensures awareness and compliance of new and revised quality processes, documentation and regulations that affect South Africa and other Africa.

Responsibilities

• Ensure Quality System awareness and compliance in South Africa.
• Achieve results associated with daily business schedule and goals as assigned.
• Plans and conduct internal audits to verify the effectiveness of the quality management system.
• Prepares/ coordinate external audits.
• Ensures purchasing/supplier controls implemented and maintained including quality warehouse oversight, distributor control and maintenance.
• Responsible for implementing, maintenance and control of 3PL warehouses, distribution center spare part depots in South Africa and other Africa.
• Responsible for managing Q-holds and temperature excursions, temperature monitoring, supplier audits, procedure creation and supporting incoming quality control at 3PL warehouses, distribution center, spare part depots in South Africa and other Africa.
• Ensures CAPA management implemented and maintained as well as continues improvements established.
• Coordinate Field Communications and Vigilance activities for South Africa.
• Ensures availability of org charts and job descriptions together with HR.
• Ensures Document Control for local South African procedures and works together locally with the Core Diagnostics on improvement projects, as well as maintaining shared services as applicable.
• Support/provide training to the organization about the Molecular Diagnostics Quality System.
• Support Management in consulting QMS training requirements.
• Input Management Review for the Commercial Affiliates.
• Act as Liaison between Abbott Molecular Regulatory, Commercial, and divisional and inter-divisional functions.
• Supports other affiliates and projects in EMEA with the quality knowledge as deemed to be required.
• Participates in AQR South African inter-divisional meetings, ensuring compliance to local regulations and GxP practices.

Education

QUALIFICATIONS AND EXPERTISE:

• A tertiary qualification in Biochemistry OR Chemistry OR Quality OR related.
• Additional Quality training is Advantageous.

Experience

• 5-7 Years’ experience in a similar role is essential, having worked in MEDICAL DEVICES or PHARMACEUTICAL
• Must have strong experience with ISO 9001 and/or ISO 13485
• Must have strong attention to detail and be self-motivated.
• Experience having dealt with countries outside of South Africa would be beneficial
• Deep understanding of Quality Systems management, Warehouse control and GxP.
• QMS auditing experience desired.