Job Description
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
The Opportunity
The role champions a culture of quality throughout the FWC Africa markets by leading a robust quality assurance program, ensuring strict compliance, and effectively managing any emergent quality and product safety issues.
Main Responsibilities
Network quality management review
- Reporting on quality performance by reviewing quality compliance and incidents, analyzing trends and patterns, identifying areas for improvement, developing recommendations and submitting as required.
- Monitoring performance of management review metrics (Quality-KPIs) and to identify, report and lead the resolution of potential challenges or opportunities to the top management as needed.
- Conducting the management reviews as per ISO 13485 requirements.
Quality system management
- Manage the QMS by monitoring implementation of policies, procedures and systems, reviewing the relevance of the system, and identifying areas for improvement, and managing its effectiveness.
- Maintain the QMS according to International Standards, Roche’s policies, modular QMS and with the Company's Quality Policy.
- Ensure communication and training of quality processes and best practice information across the Network to raise awareness of Quality Management principles.
Management of External Business Partners (BP)
- Oversee the full quality lifecycle of external business partners, including training, supplier qualification, contract definition (ensuring clear roles and responsibilities for quality-related topics like complaint management etc.), and ongoing contract management through performance reviews and implementation of corrective/preventive actions.
- Manage all QA activities related to 3PL operations, encompassing lifecycle management (evaluation, audit, monitoring, and re-evaluation) and distributor/3PL onboarding and training programs.
- Manage quality relevant requirements of distributor and 3PL contracts, ensuring performance against agreed service level standards and the implementation of necessary corrective and preventive actions, and manage distributor and 3PL onboarding and training.
Risk management
- Integrate Quality Risk Management into routine business processes and the Quality System by following the required GSPs and SOPs and conducting annual quality risk evaluation, analyze findings and implementing risk mitigation as defined.
Change control
- Ensure that the change control processes are complied with by complying with GSPs and SOPs to initiate, plan, assess, approve and implement changes.
Document control
- Manage document management systems and protocols, ensuring compliance with document management policies and practices, training staff, identifying risks, and implementing corrective actions.
- Own and maintain SOPs and Policies, including reviews and updates to ensure adherence to the relevant format, which may involve document editing.
- Manage document control processes for including tracking and ensuring timely approval and sign-off of workflows, and record management within ICL.
Operational QA management
- Comprehensive logistics and shipment oversight.
- Rigorous product integrity and cold chain management.
- Proactive non-conformance and risk management.
Local Safety Officer (LSO)
- Oversee PRI/ PSI; Scorecard: Case Quality Review.
- Oversee complaint management system compliance.
Who you are?
Required Experience and Education
- Bachelor’s degree of equivalent in a health science related field
- Bilingual capabilities: English and French
- 2-3 years in medical device and IVD industry experience with 2-3 years management experience
- Must have knowledge of: Pharmaceutical industry including regulations, QA principles from a diagnostics industry and relevant product knowledge
Required Competencies and Skills
- Achieving results
- Strategic agility
- Political savvy
- Relationship management
- Teamwork and collaboration
- Communication (verbal and written)
- Problem solving
- Situational responsiveness
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.