Kyowa Kirin International plc.
Senior QA Product Specialist – 15 Months FTC
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Senior QA Product Specialist – 15 Months FTC
Senior Quality Assurance Specialist – Global Product Supply Operations
About KKI
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 journey goes beyond drug development; it’s about weaving care into every aspect of our work to positively impact those who need it most. We’re a progressive pharmaceutical company that actively listens to patients, their families, and healthcare professionals to drive bold, impactful solutions faster. Our guiding values—Teamwork, Commitment to Life, Innovation and Integrity—anchor our mission to challenge boundaries. This integrity empowers KKI to become a truly exceptional place to work, where extraordinary impact is delivered every day.
Job Purpose
Kyowa Kirin is seeking a proactive and detail-driven Senior Quality Assurance Specialist to support our global product supply operations. This role presents an outstanding opportunity to take ownership of quality, safety, and compliance for our commercial and clinical products in a dynamic, team-focused environment.
Key Responsibilities
- Lead QA oversight for complex product supply activities with minimal direct supervision.
- Apply expert knowledge of GxP guidelines, KKI’s Quality Management System (KKS QMS), and global regulatory expectations (MHRA, FDA, EU, ICH).
- Escalate and resolve quality issues promptly and professionally across levels of the business to ensure compliance and timely resolution.
- Influence project teams to maintain GMP compliance while proactively identifying potential quality gaps early.
- Author, negotiate, and maintain Quality/Technical Agreements with third-party vendors, suppliers, and contract manufacturers.
- Review GxP documentation and CMO records to ensure compliance before product release.
- Oversee the monitoring and verification of CAPA (Corrective and Preventive Actions) implementation.
- Deliver GxP training and refresher sessions to support internal teams.
- Provide KPI reporting to QA management to drive continuous process improvement.
- Participate in product recall assessments to safeguard patient safety and uphold regulations.
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Position Requirements
Essential Qualifications
- Degree in Life Sciences (Pharmacy, Biochemistry, or related field) or equivalent professional experience.
- Extensive hands-on experience in pharmaceutical manufacturing, supply chains, or distribution.
- Strong mastery of international GxP and regulatory requirements (MHRA, FDA, EU, ICH).
- Previous QA experience in aseptic/STERILE manufacturing, with a preference for biologics or monoclonal antibodies.
- In-depth knowledge of QC testing, including stability protocols for solids, semi-solids, and parenterals.
- Working familiarity with validation, ICH guidelines, risk assessments, and standardised Quality Management Systems (e.g., ICH Q10).
- Demonstrated communication, analytical, and problem-solving skills with a results-focused approach.
- Ability to work independently, prioritise tasks effectively, and thrive in a global, virtual working environment.
- Extraordinary attention to detail and unwavering commitment to flawless execution.
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Additional Requirements
- Willingness to travel internationally as needed.
- Comfort with prolonged periods of desk-based work.
- Flexibility to work occasional early or late shifts where required.
Why Join Us?
Seeking a fixed-term commitment of 15 months, this role offers a tangible opportunity to shape global product quality standards while contributing to a life-changing mission. If you thrive in a rapidly evolving, collaborative environment and envision forging careers in pharmaceutical excellence, we’d love to hear from you.
Kyowa Kirin International is an equal opportunity employer. Direct reponses only—no external recruitment agencies please.
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