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Quality Assurance Manager, GCC
Kyowa Kirin International plc.
Dubai, UAE
Contract
Manager
Today
Quality Management SystemsGMPGDPRegulatory ComplianceAuditingCAPA
Free
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Quality Management SystemsGMPGDP
About the Role
Kyowa Kirin International seeks a Quality Assurance Manager to oversee quality for the GCC region. The role involves managing QMS, distributor oversight, product release, and regulatory compliance to ensure safe, high-quality medicines.
Key Skills for This Role
Quality Management SystemsGMPGDPRegulatory ComplianceAuditingCAPA
Responsibilities
- Lead quality oversight for the GCC Kyowa Kirin Product portfolio, ensuring product quality, safety, and regulatory compliance.
- Manage key quality activities including QMS, audits, complaints, recalls, CAPAs, and distributor and CMO oversight.
- Partner with manufacturers, distributors, and health authorities to ensure uninterrupted supply of medicines.
- Oversee product release, quality agreements, and GMP & GDP compliance across the region.
- Drive continuous improvement and operational excellence in a highly regulated pharmaceutical environment.
Requirements
- Degree in Life Sciences or equivalent
- Experience in the pharmaceutical industry
- Strong knowledge of GMP/GDP and Quality Management Systems
- Knowledge of GCC and EU pharmaceutical regulations
- Excellent analytical, problem solving, and communication skills
- Collaborative, detail oriented approach with strong integrity
- Results driven mindset, ability to thrive in a fast paced regulated environment
Full Job Posting
Overview
- Quality Assurance Manager, GCC at Kyowa Kirin International plc in Dubai, United Arab Emirates.
About Kyowa Kirin International
- Purpose is to make people smile, embedding care into everything we do.
- Inclusive pharmaceutical company focused on patients, families, and healthcare professionals.
- Culture rooted in values: Teamwork, Commitment to Life, Innovation, and Integrity.
Job Purpose
- Covering the GCC region (UAE, Saudi Arabia, Qatar, Oman, Kuwait, and Bahrain), maintain quality oversight for the GCC Kyowa Kirin product portfolio.
- Ensure highest standards of product quality, safety, and compliance.
- Manage regional Quality Management Systems (QMS), distributor and quality oversight, product release activities, and key interactions with health authorities.
- Work closely with internal and external partners to ensure patients receive safe, high quality medicines while driving continuous improvement and compliance excellence.
Key Responsibilities
- Lead quality oversight for the GCC Kyowa Kirin Product portfolio, ensuring product quality, safety, and regulatory compliance.
- Manage key quality activities, including QMS, audits, complaints, recalls, CAPAs, and distributor and CMO oversight.
- Partner with manufacturers, distributors, and health authorities to ensure uninterrupted supply of medicines to patients.
- Oversee product release, quality agreements, and GMP & GDP compliance across the region.
- Drive continuous improvement and operational excellence in a highly regulated pharmaceutical environment.
- Make a direct impact on patient access to critical medicines while shaping quality excellence across the GCC.
Position Requirements
- A degree in Life Sciences (or equivalent) and experience in the pharmaceutical industry.
- Strong knowledge of GMP/GDP, Quality Management Systems, and GCC and EU pharmaceutical regulations.
- Excellent analytical, problem solving, and communication skills.
- A collaborative, detail oriented approach with strong integrity and a focus on quality.
- A results driven mindset, with the ability to thrive in a fast paced, regulated environment.
- Ideal for a quality professional passionate about ensuring patients receive safe, high quality medicines while driving compliance and continuous improvement across the GCC region.
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