Quality Assurance Manager, GCC

at Kyowa Kirin International plc

Dubai - United Arab Emirates

WE PUSH THE BOUNDARIES OF MEDICINE.

LEAPING FORWARD TO MAKE PEOPLE SMILE

At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those who need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

Job Purpose

Covering the GCC region (UAE, Saudi Arabia, Qatar, Oman, Kuwait, and Bahrain), you will maintain quality oversight for quality oversight of the GCC Kyowa Kirin product Portfolio, ensuring the highest standards of product quality, safety, and compliance.

You'll manage regional Quality Management Systems (QMS), distributor and quality oversight, product release activities, and key interactions with health authorities. Working closely with internal and external partners, you'll help ensure patients across the GCC receive safe, high-quality medicines while driving continuous improvement and compliance excellence.

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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.
• This is an exciting opportunity to 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 who is passionate about ensuring patients receive safe, high-quality medicines while driving compliance and continuous improvement across the GCC region.