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About the Role

UCB Japan is seeking a Quality Lead, Japan to play a central role in the company's Quality strategy. This position leverages expertise in the pharmaceutical/healthcare Quality domain to manage critical Quality operations in the Japanese market, focusing on strategic decision-making and advisory roles in collaboration with global teams for quality issues and escalations.

Responsibilities

• Fulfill duties as the "Responsible Person for Quality Assurance" based on Japanese regulations.
• Manage and escalate quality-related issues and problems.
• Collaborate and negotiate with global stakeholders, providing quality guidance and advisory.
• Oversee and continuously improve the Quality Management System (QMS).
• Ensure compliance with various regulatory requirements including GMP/GDP/GQP, and lead audit/inspection responses.
• Identify, assess, mitigate quality risks, and drive continuous improvement.
• Lead deviation, CAPA, and quality investigations.
• Engage in cross-functional collaboration with Commercial, Supply Chain, Regulatory Affairs, PV, and Global Quality.
• Manage quality of external contractors (domestic manufacturers, logistics providers, etc.), including selection, evaluation, and audits.
• Ensure product quality, including traceability, shipment decisions, and recall management.
• Lead product recalls and regulatory authority responses.
• Perform duties as the Responsible Person for Quality Assurance under Japanese regulations.
• Focus on strategic decision-making and advisory rather than daily operational tasks.

Requirements

• Experience in the Quality domain within the pharmaceutical/healthcare industry with a strategic perspective equivalent to a Quality Head.
• Ability to provide direction and advice on quality issue response and escalations, including global collaboration.
• Possess a high-level quality mindset to accurately assess situations and make appropriate judgments and recommendations, with limited involvement in daily operational tasks.
• In-depth understanding of GMP/GDP/GQP/GxP and various regulations (FDA/EMA/PMDA, etc.).
• Knowledge of deviation/CAPA/audit response, QMS operation/improvement, and ability to make appropriate judgments and provide advice during quality issues.
• Stakeholder Management: Ability to communicate smoothly with business department stakeholders and promote work by understanding diverse perspectives.
• People Management: Experience managing a small team is preferred.
• English proficiency: Ability to communicate orally and in writing with global members in English, and to accurately explain Japanese requirements and issues and reach consensus without prior preparation.

Skills

• Quality Assurance
• Quality Management System (QMS)
• GMP
• GDP
• GQP
• GxP
• Regulatory Compliance
• Auditing
• Risk Management
• Deviation Management
• CAPA Management
• Stakeholder Management
• People Management
• English Communication

Location

• Japan

Work Type

• Full-time

Experience Level

• Mid-level to Senior

Education Level

• Pharmacist qualification preferred

About the Company

• UCB is a global biopharmaceutical company focused on the neurology and immunology domains.
• Approximately 8,500 employees worldwide are inspired by patients and driven by science.
• At UCB, creating value is prioritized over simply completing tasks.
• The company strives for results for patients by embracing challenges, collaborating, and pursuing innovation.
• A culture of compassion and support is embedded, where everyone is respected, accepted, and has equal opportunities to do their best.
• UCB consistently aims for 'beyond,' delivering human-centered value to patients, employees, and the planet.
• Working at UCB allows for personal growth, career freedom, and maximizing potential.

Equal Opportunity

• UCB values equal opportunity, and all hiring decisions are made without regard to any legally protected attribute.
• For special accommodation needs during the selection process, please contact EMEA-Reasonable_Accommodation@ucb.com.