Pan-Africa Quality Assurance Audit & Certification Lead
Roche Kenya
Quick Take
Lead quality assurance audits and regulatory compliance across Roche's African medical device and diagnostics networks, managing ISO certifications, inspections, and cross-border quality governance from a Nairobi base.
7–10 years of hands-on audit leadership in medical devices/diagnostics, fluent bilingual capability (English & French), and deep expertise in ISO 13485 and ISO 9001 standards.
Senior role at a global healthcare leader with pan-continental impact, competitive salary (KES 350–600k/mo), and the opportunity to shape quality culture across francophone and anglophone Africa.
Job Description
Roche, the global leader in personalised healthcare, is seeking a seasoned Pan-Africa Quality Assurance Audit & Certification Lead to anchor its Quality & Regulatory (Q&R) function across the African continent. Based in Nairobi, this senior role sits at the intersection of audit strategy, regulatory compliance, and cross-border quality governance — covering Roche's distribution networks, diagnostic hubs, and third-party partners spanning francophone and anglophone Africa.
This is a high-impact position for a bilingual quality professional who thrives in complex, multi-jurisdictional environments and can translate audit findings into tangible business improvements. You will serve as the primary interface for certification bodies and regulators, protect Roche's ISO certifications, and champion a culture of continuous compliance readiness across the region.
- Design and execute a risk-based annual internal and external audit strategy covering all African networks, distribution hubs, and critical third-party partners.
- Lead as principal auditor for internal quality management system (QMS) audits, evaluating compliance against ISO 13485, ISO 9001, and applicable local medical device and In Vitro Diagnostics (IVD) regulations.
- Conduct audits and review documentation in both English and French, ensuring accurate interpretation of local operational contexts across African territories.
- Manage external certification audits and regulatory inspections region-wide, acting as the primary point of contact and host for the regional Q&R chapter.
- Track and validate Corrective and Preventive Actions (CAPAs), partnering with local teams to ensure root-cause analyses are thorough, actionable, and sustainably closed.
- Safeguard existing ISO and regulatory certifications while leading compliance readiness initiatives for Roche's expansion projects across the continent.
- Monitor the evolving African regulatory landscape — including SAHPRA, NAFDAC, EDA, TFDA, and PPB — to proactively align audit programmes with changing requirements.
- Establish, monitor, and report on Quality Key Performance Indicators (KPIs) across regional networks, delivering data-driven insights to Q&R chapter leadership.
- Standardise cross-border workflows including warehousing, cold chain diagnostics logistics, distribution, and post-market surveillance.
- Build and sustain a culture of audit readiness through targeted training, workshops, and mock audit simulations delivered in both English and French.
- Work within structured vendor and partner frameworks (e.g., BPMF) to ensure third-party quality alignment.
- Demonstrate at least 7–10 years of hands-on audit leadership within the medical device, diagnostics, or broader life sciences sector — not just audit support, but owning the audit cycle end-to-end.
- Apply deep working knowledge of ISO 13485 and ISO 9001 standards in audit execution, gap analysis, and CAPA validation across multi-site operations.
- Navigate and interpret regulatory frameworks from multiple African jurisdictions simultaneously, identifying compliance risks before they escalate.
- Communicate audit findings and remediation plans fluently in both English and French — written and verbal — across culturally diverse teams and senior stakeholders.
- Influence cross-functional and cross-border teams without direct authority, driving compliance ownership at the local level.
- Manage external certification bodies and regulatory inspectors as a credible technical counterpart and regional host.
- Use data and quality KPIs to construct executive-level narratives that inform strategic decision-making.
- Manage competing audit timelines and multi-country travel schedules with strong organisational discipline.
- Hold a relevant professional certification such as ISO 13485 Lead Auditor, ISO 9001 Lead Auditor, or equivalent (e.g., CQA, ASQ).
Roche offers a competitive, globally benchmarked compensation package commensurate with the seniority and pan-continental scope of this role. The estimated monthly gross salary range is KES 350,000 – 600,000, reflecting the 7–10 years of specialised experience required. Exact remuneration will be confirmed during the offer stage based on qualifications and experience.
- Comprehensive medical cover for employee and dependants
- Performance-based bonus aligned to regional quality outcomes
- International travel and subsistence allowance for audit missions
- Professional development and continuous learning support
- Access to Roche's global employee benefits and wellness programmes
Ideal candidate: You are a bilingual (English & French) quality assurance professional with a proven track record of leading complex, multi-country audit programmes in the medical device or diagnostics industry. You are equally comfortable presenting to regulators in Lagos as you are facilitating a CAPA workshop in Nairobi or Casablanca. You understand African regulatory bodies intimately and you build compliance cultures rather than merely checking boxes.
Do NOT apply if: You have fewer than 7 years of direct audit leadership experience in a regulated life sciences environment, if you have no working knowledge of ISO 13485 or ISO 9001, if you are not comfortable with regular pan-African travel, or if you cannot operate professionally in both English and French.
- Visit the Roche careers portal at roche.com/careers and search for the Pan-Africa Quality Assurance Audit & Certification Lead vacancy.
- Submit your updated CV and a concise cover letter (maximum one page) outlining your audit leadership experience and language proficiency.
- Shortlisted candidates will be contacted for an initial screening call followed by structured panel interviews.
- Note: Roche will never request payment at any stage of the recruitment process. If in doubt, contact Roche Kenya directly through official channels.
Requirements Breakdown
Must Have
- Minimum 7–10 years of hands-on audit leadership (not support) in medical device, diagnostics, or life sciences
- Fluency in English and French (spoken and written) for audits and documentation review across African territories
- Deep working knowledge of ISO 13485 (medical devices) and ISO 9001 standards in audit execution and gap analysis
- Proven experience managing external certification audits and regulatory inspections in highly regulated environments
- Track record of CAPA validation, root-cause analysis, and driving sustainable compliance improvements
Nice to Have
- Certification as a Lead Auditor (ISO 13485 or equivalent recognised body)
- Familiarity with African regulatory bodies (SAHPRA, NAFDAC, EDA, TFDA, PPB) and their approval processes
- Experience working with vendor/partner quality frameworks (e.g. BPMF) or third-party auditing programmes
- Background in cold chain logistics, warehousing, or post-market surveillance in medical device or IVD sectors
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Salary Context
Above-market senior-level compensation for a Pan-Africa Quality Assurance Lead in Nairobi.
At KES 350–600k/month, this role sits in the upper quartile for quality leadership roles in Kenya, reflecting Roche's global scale and the seniority and bilingual complexity required. Salary variation depends on audit certifications, regional regulatory experience, and language fluency; candidates with SAHPRA or NAFDAC-specific knowledge typically command higher offers.
About Roche Kenya
Roche is a global leader in personalised healthcare and diagnostics, with a significant presence across African distribution networks and diagnostic hubs. In Kenya and across the continent, Roche operates at the intersection of innovation and regulatory rigour, providing critical medical devices and in vitro diagnostics to healthcare systems. Working at Roche means joining a organisation that prioritises quality, compliance, and impact in one of the world's most dynamic and challenging healthcare markets.
Likely Interview Questions
- 1
Walk us through a complex, multi-country audit programme you designed and executed—what risks did you identify, and how did you prioritise remediation across different regulatory jurisdictions?
- 2
Describe your experience auditing in French-speaking territories. How do you ensure accurate interpretation of local operational contexts and regulatory requirements when language barriers exist?
- 3
Tell us about a time you discovered a significant compliance gap during an audit. How did you work with local teams to develop a root-cause analysis and CAPA that actually stuck?
- 4
Roche operates across anglophone and francophone Africa with varying regulatory maturity. How would you standardise audit workflows and quality KPIs while respecting local regulatory nuances?
- 5
What experience do you have with ISO 13485 recertification audits, and how have you previously managed the tension between audit findings and business continuity in a regulated medical device environment?
Application Tips
Highlight specific audit programmes you have led end-to-end—number of sites audited, regulatory bodies engaged, and measurable compliance improvements achieved (e.g. '98% CAPA closure rate within SLA').
Emphasise bilingual audit capability with concrete examples: audits conducted in French, documentation reviews, and interaction with francophone regulators—this is a critical differentiator for this Pan-Africa role.
Demonstrate proactive regulatory intelligence: mention any experience monitoring or adapting to changes from SAHPRA, NAFDAC, TFDA, or other African regulators, and how you've translated that into audit strategy shifts.
Career Path
Roles that lead here
Where this leads
Skills & Keywords
Honest Assessment
Green Flags
- Roche is a world-leading pharmaceutical and diagnostics company with genuine scale and impact in Africa—this is a prestigious employer with strong reputation for quality and compliance culture.
- The salary range (KES 350–600k/mo) is competitive and reflects the seniority, bilingual complexity, and regional scope of the role—clear investment by the employer in attracting talent.
- The role explicitly mentions expansion projects and continuous compliance readiness initiatives, signalling growth opportunities and the chance to shape quality culture in an emerging market.
- Pan-Africa scope from a Nairobi hub is a rare and strategic positioning that offers continental visibility, regulatory intelligence across multiple jurisdictions, and genuine leadership impact.
Watch Out
- The role description is extensive but does not mention specific teams, reporting lines, or mentoring/people management structure—clarify whether this is truly a leadership role with direct reports or a specialist IC role before applying.
- While bilingual capability (English & French) is essential, no detail is given on how language proficiency will be assessed during the interview process or whether interpretation support is available for francophone audits.
- The posting lists an unusually broad scope (internal audits, external certifications, CAPA management, regulatory monitoring, training, KPI reporting) for a single individual; confirm during the interview whether budget, team support, or tools are in place to make this achievable.
A Day in the Life
Your week might begin with a video call with SAHPRA inspectors to prepare for an upcoming compliance visit at a Johannesburg distribution hub, followed by a review of CAPA documentation from a Lagos diagnostic centre submitted in French. Mid-week, you'll facilitate a training workshop via Teams for audit-readiness improvements across four countries, analyse regional QKPIs for the Q&R chapter leadership meeting, and conduct a remote audit of a third-party partner's cold chain logistics in Kampala. Thursday could involve drafting a risk-based audit plan for the next financial year and coaching your contact at a Kenyan warehouse on root-cause analysis techniques. The role blends strategic planning, regulatory dialogue, hands-on audit work, and cross-border quality mentoring—all underpinned by the need to move fluidly between English and French contexts and manage competing compliance timelines across the continent.
Frequently Asked Questions
What qualifications do I need to be a Pan-Africa Quality Assurance Audit & Certification Lead at Roche Kenya?
You need a minimum of 7–10 years of hands-on audit leadership (not just support) in medical devices or diagnostics, fluency in both English and French, and deep expertise in ISO 13485 and ISO 9001. A Lead Auditor certification (ISO 13485 or equivalent) is highly valued but not explicitly required; familarity with African regulators like SAHPRA and NAFDAC is a significant advantage.
Is the Pan-Africa Quality Assurance Audit & Certification Lead role at Roche Kenya remote or office-based?
The role is based in Nairobi, but given the Pan-Africa remit, expect frequent travel across African territories (likely 30–40% of time) to conduct audits, manage inspections, and engage with local teams and regulators. Some meetings may be virtual, but fieldwork and in-person regulatory engagement are core to the position.
How much does a Pan-Africa Quality Assurance Audit & Certification Lead earn at Roche Kenya?
The posted salary range is KES 350,000–600,000 per month, which is competitive and above-market for this seniority level in Kenya. Your final offer will depend on your audit certifications, specific regulatory experience, bilingual proficiency, and track record of compliance impact.
What are the career growth opportunities for this role at Roche?
This is a senior specialist/leadership role with clear visibility to regional and global Quality & Regulatory functions. Strong performers often progress to Regional Quality Director, VP Quality, or Global Head of Audit roles within Roche or multinational healthcare companies. The continental scope and Roche's growth trajectory offer genuine advancement potential.
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