Senior QA Product Specialist – FTC

Overview

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 that 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.

Kyowa Kirin is seeking a proactive and detail‑driven Senior Quality Assurance Specialist to support our global product supply operations. This is an excellent opportunity to play a key role in ensuring the quality, safety and compliance of our commercial and clinical products within a collaborative, fast‑moving environment.

Key Responsibilities:

• Lead QA oversight for complex product supply activities with minimal supervision.
• Apply strong working knowledge of GxP, KKS QMS, and global regulatory expectations (MHRA, FDA, EU, ICH).
• Communicate quality issues promptly and professionally across the business to drive compliant, timely resolutions.
• Influence project teams to ensure GMP compliance and identify quality gaps early.
• Prepare, negotiate and maintain Quality/Technical Agreements with third‑party manufacturers and suppliers.
• Review GxP documentation and CMO records to support compliant product release.
• Monitor and verified effective implementation of CAPAs.
• Deliver GxP training and refresher sessions to internal teams.
• Provide KPI reporting to QA management to support continuous improvement.
• Participate in product recall assessments to protect patient safety.

Position Requirements

• A degree in Life Sciences or equivalent.
• Strong experience in pharmaceutical manufacturing, supply or distribution.
• Excellent understanding of international GxPs and regulatory requirements.
• Previous QA experience in aseptic manufacturing (biologics/monoclonal antibodies advantageous).
• Knowledge of QC and stability testing for solids, semi‑solids and parenteral.
• Familiarity with validation requirements, ICH guidelines and Quality Management Systems (e.g., ICH Q10).
• Strong communication, analytical and problem‑solving skills.
• Ability to work independently, manage priorities and operate effectively in a virtual, global environment.
• High attention to detail and commitment to flawless execution.

• Ability to travel internationally as needed.
• Comfortable with extended periods of desk‑based work.
• Flexibility for occasional early/late working.

This 15 months fixed‑term role offers the chance to make a meaningful impact on global product quality while working with a supportive, mission‑driven team. If you’re results‑oriented, thrive in a fast‑paced environment and want to contribute to delivering life‑changing medicines, we’d love to hear from you.