Vacancies at Roche Kenya

The Opportunity

Roche Diagnostics Africa is seeking a Policy and Government Affairs Partner to shape and influence policy implementation across the continent through support of affiliate teams. The role would be based on the African continent for consistent engagement with regional and/or local stakeholders who have regional influence and to enable travel to countries across the continent as needed.  This role has both strategic and tactical elements to support initiatives that span multiple countries and for linkage at the regional level. This role is about the “how” and the “what” in regional health policy. You will focus on health policy and government affairs topics across the African continent.  

The successful incumbent will serve as a point of contact for health policy for Africa to regional intergovernmental organisations and related local agencies/NGOs. You will engage with regional level stakeholders, provide insights into African regional health priorities and policy agendas and provide support for the local affiliate policy teams. This will be done within the context of the Healthcare Access Chapter, in delivering the Roche Diagnostics 10 Years Africa Strategy, and a team effort together with other policy roles in the organisation.

You will bring insights into the political and economic healthcare ecosystem for key regions on the African continent, build strong relationships with regional or national stakeholders that influence across multiple countries and advocate for patient access to healthcare no matter where they live.  

Key Challenges:

• Build a deep understanding of the health ecosystems across the African continent to set policy agenda priorities including the environments, institutional and political landscapes with emphasis on key priority countries of the Africa Strategy. 
• Actively engage and build relationships with political stakeholders and key influencers of health policy agendas at regional and national levels in coordination with global health policy leads, EEMEA-LATAM policy teams and the Africa Healthcare Access Chapter to enable removal of barriers and bring key disease area and health topics to the priority agenda for rapid, broad and sustainable access to Roche innovations for patients.
• Conduct research, analyse current healthcare policies, evaluate the effects of proposed legislation, and report on findings within the Healthcare Access Chapter, EMEA LATAM region and Area Africa to identify unmet needs and opportunities.
• Influence political and social events to increase voice around healthcare issues related to key business initiatives under the strategic initiatives of Roche in Africa both internally and externally.
• Build supporting tools and knowledge resources (e.g. best practice) for implementation of policy agenda at local levels that deliver clear, evidence-based and compelling positions for governments and key influencers including monitoring and evaluation metrics to track momentum for access and lessons learned and communication mechanisms (e.g. communities of practice).
• Support affiliate access, policy and commercial teams in local activities to minimise gaps/hurdles to access in support of health system strengthening initiatives and public private partnerships.  Such projects include Global Access Program, Africa Breast Cancer Ambition (ABCA), Women's Health, UHC, NCDs and local affiliate pilot projects for access. 

Who you Are:

• Required: A degree in Science or the Social Sciences.
• Highly desirable: Master Degree in Policy, Health Economics or Health Financing.
• Significant experience in the pharmaceutical or health / medical device / laboratory industry with experience relating to market access, government affairs and health policy. Experience in multiple markets is an advantage.
• Fluency in Written and Spoken English is mandatory. Ability to read and speak French is an advantage

Impact will be measured by:

• Contribution to regional/area business objectives, regional/area business growth and increased patient access across Africa.
• Delivery of key initiatives that result in changes to regional or local policies leading greater access within agreed timelines.
• Development of key relationships within the African health policy ecosystem to shape policy agendas.
• Creation of health policy engagement and shaping capabilities within the local teams across Africa.
• Interpersonal skills for successful collaboration within highly matrixed cross-functional teams .
• Critical thinking, strategic mindset, problem solving, and analytical skills.
• Ethical mindset and good understanding of relevant compliance principles and regulations.
• Strong influencing and negotiation skills: confirmed abilities to influence others without authority and mobilise people behind a common purpose and strategy.

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The Opportunity

Roche in Kenya has a vacancy for a Regional Quality Manager for the East Africa region who will ensure the  maintenance and continual improvement of the Affiliate’s quality system, in order to ensure compliance with the regulations and Roche requirements. You as our successful candidate will support in overseeing warehousing and distribution partners within the East Africa region regarding the implementation, utilization and continual improvement of the quality system, in order to ensure compliance with the regulations and Roche requirements, and an uninterrupted supply of quality products to the patients.

Key Challenges

Regional Warehousing and distribution partners:

• Support selection of new partners by active assessment support during the due-diligence phase.
• Oversee closing of gaps and adherence to long-term Compliance Plans.
• Act as a first-level support for warehousing and distribution partners concerning quality-related topics including temperature excursions, complaints and issues which can also be handled directly via the respective communication channels).
• Oversee the implementation, utilization and continual improvement of the quality system at the 3rd party during the manage phase.
• Execute trainings with individual partners based on their specific needs.

Pharmacies, Hospitals and other involved service providers:

• Realize training needs and execute accordingly

Other:

• Support in preparation and facilitation of regional workshops
• Monitor health authority trends and discussions for the countries within the region

Implement and Maintain the Affiliate Quality System

• Maintain up to date knowledge of the relevant functional, legal and GMP/GDP requirements.
• Documentation Management- Develop and Maintain local procedures in compliance with the Global Pharmaceutical Quality System Documents.
• Perform Self Inspections.
• Manage Planned (Changes, CAPAs) and unplanned events (Complaints, Recalls, Deviations and Returns).
• Training of personnel involved in GxP activities.
• Quality Risk Management.
• Dealing with internal and external inquiries about product quality.
• Qualification of distributors and customers.

Ensure an uninterrupted supply of the products to the market.

• Release commercial product batches to the local market and Investigational Medicinal products to the local clinical investigation centers, according to the local regulations, marketing Authorizations and Clinical Trial Authorization.
• Ensure compliance with GDP guidelines and regulations for the products distributed locally.
• 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.

Management of GxP Out-sourced activities.

• Maintain Quality Agreements with local contracted third parties (Warehouse & Distribution)
• Perform audits of contracted third parties.

Who you Are as our ideal candidate:

• You hold a university degree preferably in one of the following or related scientific disciplines: pharmacy, medicine, pharmaceutical chemistry and technology, or biology. Any other university degree can be considered with a proven record of work experience in the pharmaceutical industry working closely with warehousing and distribution partners (e.g. regulatory, supply chain, commercial operations).
• You have at least two years of experience in Quality Control and/or Quality Assurance in a pharmaceutical environment of an affiliate,  direct market country or sub-regional center dealing with warehousing and distribution partners.
• You have basic knowledge in pharmaceutical packaging/redressing operations.
• You have experience in the areas of Quality Control and/or Quality Assurance.
• You exhibit excellent written and oral communication skills, analytical and problem solving skills and a high degree of proficiency in English.