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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.