Quality & Regulatory Manager - Vigilance Contact

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.

Come and join a family-owned global company with a long-term vision, and a human-centered culture.

The successful candidate will be responsble for maintenance and continual improvement of the quality system, in order to ensure compliance with the regulations and bioMerieux requirements, and an uninterrupted supply of quality products to the patients.

What will your responsibilities be?

1. Implement and maintain the Quality System

•    Maintain up to date knowledge of the relevant legal requirements and GMP regulations
•    Documentation management – Develop and maintain local procedures, in compliance with the Global Quality System Documents
•    Effectively Manage ISO 9001 and ISO 13485 for the South Africa SUB
•    Perform distributor Audits
•    Manage Complaints, Recalls and Returns
•    Handle Deviations and Investigations
•    Training of personnel involved in Divisional Standard activities
•    Change control
•    Manage of local Corrective and Preventive Actions
•    Quality Risk Management
•    Dealing with internal and external inquiries about the products quality

       2. Ensure an uninterrupted supply of the products to the market

•    Release commercial product batches to the local market and Investigation Medicinal Products to the local clinical investigation centers, according to the local regulations

•    Ensure compliance with guidelines and regulations for the products distributed locally

•    Ensure compliance with guidelines and regulations for the products manufactured
•    Ensure batch traceability for all batches received and distributed by the local warehouse
•    Ensure appropriate supervision of the supply chain, and existence of additional controls for the cold chain

       3. Management of Divisional Standards out-sourced activities

•    Maintain Quality Agreements with local contracted third parties (Warehouse & Distribution, Contracted manufacturer, Contracted Laboratory)
•    Perform audits of contracted third parties

The successful candidate will have:

•    University degree in one of the following or related scientific disciplines: pharmacy, medicine, pharmaceutical chemistry and technology or microbiology

•    3 - 5 years' experience in the pahamaceutical/medical devices industry

•    Excellent written and oral communication skills
•    Analytical and problem solving skills

•    High degree of proficiency in the local language and in English

bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.