Head of Quality Assurance, Middle East & Africa
| Location | Douala, Cameroon |
| Date Posted | June 25, 2021 |
| Category |
Administration
|
| Job Type |
Full-time
|
| Currency | CFA |
Description
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
Astellas is currently hiring a Head of Quality Assurance, Middle East & Africa, to be based in Dubai, UAE. The role will be reporting directly into the Director, MEAR QA Lead, International Markets
Purpose of the Position:
- To independently act as the Product Quality Operations Lead for the Middle East & Africa (MEA) Area covering the MENA/SSA (Middle East, North Africa, Sub-Saharan Africa) and South Africa Affiliates.
- Ensure implementation and maintenance of a Quality Management System, which is compliant with applicable GMP and GDP Guidelines, local legislation and Astellas corporate quality assurance requirements and is proportionate to the scope of wholesale distribution and marketing authorisation holder activities undertaken by or on behalf of the affiliate.
- To collaborate with the GDP Responsible Person for Astellas Pharma International BV and ensure alignment with the MENA/SSA Affiliate Quality Management System.
- Ensure all Astellas products, personnel and third parties conform to the applicable regulatory and company quality assurance requirements and these requirements are clearly understood by all relevant stakeholders.
- Independently provides QA oversight for Quality activities for Distribution Business Partner companies for distribution of Astellas products in the MEA territory. Provides oversight of the batch release strategy for Astellas drug products into MEA. Ensures timely release of product and facilitates the resolution of all deviations, non-conformances and other batch related issues.
- Audit local suppliers and third parties providing GMP/GDP activities and report observations in line with Astellas procedures.
- Review local legislation developments, and advise the relevant responsible persons (QA Sub-region lead) to initiate changes to QA policies and processes as necessary to comply with changes in regulation.
- Promote continuous improvement, risk reduction activities and prepare an annual action plan.
Requirements for the Role:
- Minimum of 5 to 7 years experience in a similar role within the MEA region
- Quality Assurance experience within the pharmaceutical industry is essential
- Good understanding of regional GMP/GDP requirements and directives
- Proven team management skills, including global and/or regional and/or local matrix leadership, having worked in cross functional teams.
- Excellent communication skills and ability to develop and maintain good working relations with internal and external stakeholders. Arabic and French skills would be a plus.
- Science based degree (Pharmacy preferred).
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.