Quality Assurance Lead, Diagnostics Southern Africa Network at Roche

The Position

• Are you passionate about fostering a culture of quality and safety? We are searching for an experienced Quality Assurance Lead to champion excellence across our Southern Africa Network (SAN) to be based in Johannesburg. In this critical role, you will spearhead our robust quality assurance program, ensuring unwavering compliance, managing emerging issues, and driving continuous improvement across all quality-related aspects.
• Bring your expertise to an industry leader, where your contribution will resonate regionally and globally.

Key Challenges:

• Ensuring Quality Excellence Across The Network: Oversee detailed quality performance reporting, management reviews, and quality improvement initiatives in line with ISO 13485 requirements and international standards.  
• Quality Management Systems (QMS): Implement, maintain, and assess policies and procedures to ensure the SAN QMS remains a best-in-class system.
• Managing Business Partnerships: Forge strong relationships with external business partners, ensuring supplier quality, 3PL onboarding, and aligned performance management.  
• Risk and Change Control Management: Integrate quality risk principles and manage change control processes to address evolving needs and compliance requirements.  
• Operational Quality Assurance Oversight: Be the guardian of logistics, product integrity, and system non-conformance while ensuring safety protocols and customer satisfaction.
• Compliance with Documentation and Processes:** Ensure seamless document management, SOP adherence, and effective record control across workflows. 
• This position involves strong cross-functional collaboration with both internal teams—spanning Supply Chain, Regulatory, Sales, Medical Affairs, and more—and key external stakeholders such as regulatory authorities, service providers, and government departments.

Who you are as our ideal candidate:

We are seeking a proactive, strategic, and skilled leader with an exceptional background in quality assurance. You will bring:

• Qualifications & Experience: A postgraduate qualification (NQF 9) in a health sciences field and at least 10 years of experience in the commercial pharmaceutical or medical device industry, including a minimum of 5 years in a management position.
• Knowledge and Expertise: An in-depth understanding of the pharmaceutical sector, including regulations and commercial business management practices.
• Skills and Attributes: You excel at achieving results and fostering strategic agility. You navigate complex business landscapes with political savvy, build trusted relationships, and inspire collaboration across teams. Strong problem-solving, communication, and responsiveness define your leadership style.
• Flexibility: The ability to travel nationally and internationally as required.