Cairo, Cairo, Egypt · Hybrid
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 …
Skills: ISO 13485 Auditing, ISO 9001 Auditing, Quality Management System (QMS), Medical Device Regulations, In Vitro Diagnostics (IVD)
Basel, Basel-City, Switzerland · On-site
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 …
Skills: Machine Learning, Language Models, Unsupervised Learning, Pytorch, Neural Networks
Hefei, Anhui, China · On-site
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 …
Skills: Medical Communication, Medical Education, Market Information Collection, Microsoft Excel, Microsoft PowerPoint
Indianapolis, Indiana, United States · On-site
$63k–$117k/yr
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 …
Skills: SAP SD, Supply Chain Management, Order Management, Inventory Management, Business Analysis
Indianapolis, Indiana, United States · Remote OK
$64k–$118k/yr
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 …
Skills: Customer Training, Problem Solving, Project Management, Consultative Selling, Histology Application Support
Xining, Qinghai, China · On-site
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 …
Skills: Medical Communication, Medical Education, Market Intelligence, Microsoft Excel, Microsoft PowerPoint
San José, Costa Rica · On-site
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 …
Skills: SAP S/4HANA, SAP Authorizations, Financial Compliance, Project Management, Fit-to-Template Assessment
Santo Domingo, Distrito Nacional, Dominican Republic · On-site
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 …
Skills: Team Leadership, Project Management, Data Analysis, Stakeholder Management, Customer Experience
Nanjing, Fujian, China · On-site
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 …
Skills: Medical Communication, Medical Education, Market Information Collection, Microsoft Excel, Microsoft PowerPoint
South San Francisco, California, United States · Hybrid
$162k–$301k/yr
Why Genentech We’re passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity while boldly p…
Skills: Brand Strategy, Market Analysis, Customer Journey Mapping, Competitive Assessment, Cross-functional Leadership
Madrid, Community of Madrid, Spain · On-site
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 …
Skills: CDISC Standards, Semantic Modelling, Master Data Management, Metadata Management, Clinical Data Management
South San Francisco, California, United States · On-site
$110k–$120k/yr
We advance science so that we all have more time with the people we love. The Department of Human Genetics at Genentech is seeking a highly motivated Postdoctoral Fellow (Computational) to develop and apply novel statist…
Skills: Computational Biology, Bioinformatics, Statistical Genetics, Rare-Variant Association Testing, Protein Structure Analysis
Shanghai, Shanghai, China · On-site
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 …
Skills: Medical Communication, Medical Education, Market Information Collection, Microsoft Excel, Microsoft PowerPoint
San Salvador, San Salvador, El Salvador · On-site
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 …
Skills: Scientific Excellence, Stakeholder Management, Clinical Evidence Generation, Medical Compliance, Patient Journey Mapping
Santo Domingo de Guzmán, Distrito Nacional, Dominican Republic · On-site
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 …
Skills: Scientific Excellence, Stakeholder Management, Clinical Evidence Generation, Medical Compliance, Patient Journey Mapping
Kaiseraugst, Aargau, Switzerland · On-site
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 …
Skills: CapEx Project Execution, Process Engineering, Matrix Leadership, Business Case Development, Feasibility Assessments
Wuhu, Anhui, China · On-site
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 …
Skills: Customer Relationship Management, Medical Communication, Academic Promotion, Disease Area Management, Clinical Pathway Optimization
Panama City, Panamá Province, Panama · On-site
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 …
Skills: Scientific Excellence, Stakeholder Management, Medical Compliance, Data Generation, Clinical Trials
Subang Jaya City Council, Selangor, Malaysia · On-site
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 …
Skills: Compliance Communications, Content Creation, Administrative Support, Stakeholder Management, Corporate Governance
pune, Maharashtra, India · On-site
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 …
Skills: ERP Solution Architecture, System Integration, MuleSoft, CPI, Convergent Mediation
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Drive and maintain the Quality Management System across Sub-Region Africa to ensure compliance with ISO 13485 and global quality standards. Design and execute risk-based internal and external audit strategies for networks, distribution hubs, and third-party partners.
Requires a Bachelor's degree in Life Sciences or a related field and mandatory ISO 13485 and ISO 9001 Lead Auditor certifications. Candidates need 7-10 years of QA experience in medical devices or diagnostics, with professional fluency in both English and French.
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.
Roche Diagnostics Africa is seeking a Bilingual Pan-Africa Quality Assurance Audit and Certification Lead to join them in either one of these locations: Nairobi, Accra or Cairo.
The Opportunity
As the Pan-Africa Quality Assurance Audit and Certification Lead, you play a vital role within the Africa Quality and Regulatory Chapter. Operating within the highly regulated Medical Devices and In Vitro Diagnostics sector, you drive, govern, and maintain the Quality Management System (QMS) across all Sub-Region Africa networks to ensure compliance with global quality and ISO 13485 standards.
This opportunity is for an individual who is an analytical thinker with a diplomatic touch, who knows how to hold the line on compliance while maintaining excellent working relationships with local teams and external partners. We are looking for an ISO 13485 certified Lead Auditor with a deep understanding of medical devices and In Vitro Diagnostics regulatory environments.
Design and execute a risk-based annual internal and external audit strategy for all networks, distribution hubs, and critical third-party partners across Africa.
Lead as the principal auditor for internal quality management system audits, evaluating compliance against ISO 13485, ISO 9001, and local medical devices and In Vitro Diagnostics regulations.
Conduct audits and review documentation seamlessly in both English and French, ensuring accurate interpretation of local operations across African territories.
Manage external certification audits and regulatory inspections across the region, serving as the primary point of contact and host for the regional chapter.
Track and validate Corrective and Preventive Actions (CAPAs), partnering with local teams to ensure root-cause analyses are robust and effective.
Safeguard existing certifications and lead compliance readiness for expansion projects across Africa.
Monitor the evolving regulatory landscape in Africa (including regulatory bodies like SAHPRA, NAFDAC, EDA, TFDA, and PPB) to proactively align audit initiatives with changing laws.
Establish and monitor Quality Key Performance Indicators (KPIs) across regional networks, providing data-driven insights to the Q&R Chapter leadership.
Standardize cross-border workflows, including warehousing, cold chain diagnostics logistics, distribution, and post-market surveillance.
Foster an ongoing culture of audit readiness through targeted training, workshops, and mock simulations delivered in preferably both English and French.
Who You Are as an Ideal Candidate
We are seeking an experienced individual in leading audits within the medical device, diagnostics, or life sciences industries. You should have a track record of turning complex audit non-conformances into actionable, pragmatic business improvements. Preferably you are bilingual (English & French) and have strong communication skills with the ability to influence and collaborate across diverse cultures and geographies. You also need to have experience working within structured vendor or partner frameworks (like a BPMF).
Your qualifications include:
Education: Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy, Quality Management, or a related technical discipline.
Certifications: Certified Lead Auditor for ISO 13485 and ISO 9001 (e.g., IRCA registered) is mandatory.
Language Capabilities: Professional fluency in both English and French is desired. You are fully confident in auditing, writing technical reports, and communicating with regulatory authorities in both languages.
Experience: 7-10 years of experience in Quality Assurance/Compliance within the Medical Devices or In Vitro Diagnostics industry.
Regional Auditing: Proven experience managing or executing multi-country regional audit programs, ideally spanning both Anglophone and Francophone Africa.
Operations Knowledge: Strong operational understanding of hub-and-spoke distribution models, cold chain requirements for diagnostics, and post-market surveillance.
Regulatory Interaction: Prior experience interacting with Notified Bodies and National Regulatory Authorities across key African markets.
Mobility: Willingness to travel regionally up to 30% (optimized through a hybrid remote/on-site assessment model).
Why this Opportunity?
If you thrive on transforming complex compliance frameworks into pragmatic business solutions, we want you on our team. You will be the champion of our Quality Management System (QMS), the mentor to our internal auditing talent, and the strategic bridge between our local affiliates and Global Q&R and Audit teams.
Note that a full job description is available at request.
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 a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI). For more information, please visit https://careers.roche.com Read our community guidelines here: https://www.roche.com/some-guidelines.htm #Roche #Biotechnology #Pharmaceuticals #Diagnostics #Healthcare #PersonalisedHealthcare #GreatPlaceToWork #Innovation
Offices: Grenzacherstrasse, Switzerland 🇨🇭 , 4070, CH · 4414 Lake Boone Trail, Raleigh, NC 27607, US · 7070 Mississauga Rd, Mississauga, ON L5N 5M8, CA · Calle Dionisio Derteano 144, San Isidro, Lima 15047, PE · 333 Buckhead Ave NE, Atlanta, GA 30305, US
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI). For more information, please visit https://careers.roche.com Read our community guidelines here: https://www.roche.com/some-guidelines.htm #Roche #Biotechnology #Pharmaceuticals #Diagnostics #Healthcare #PersonalisedHealthcare #GreatPlaceToWork #Innovation
Offices: Grenzacherstrasse, Switzerland 🇨🇭 , 4070, CH · 4414 Lake Boone Trail, Raleigh, NC 27607, US · 7070 Mississauga Rd, Mississauga, ON L5N 5M8, CA · Calle Dionisio Derteano 144, San Isidro, Lima 15047, PE · 333 Buckhead Ave NE, Atlanta, GA 30305, US
