Regional Quality Manager, East Africa

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.
  

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.
  

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.