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About the Role

The Quality Partner plays a crucial role in supporting quality management within the Japanese market. This position involves close collaboration with global and local departments, including Quality, Supply Chain, Safety, and Regulatory Affairs, to maintain and continuously improve product quality and quality systems. The role fosters a collaborative environment where diverse team members share knowledge and expertise.

Responsibilities

Lead the operation and improvement of the quality management system in the Japanese market, ensuring high-quality operations and regulatory compliance.
Manage the progress of quality-related tasks and ensure timely completion.
Implement corrective and preventive actions for audit and inspection findings.
Manage and evaluate the quality of external contractors and suppliers.
Execute product release decisions and traceability management.
Identify quality risks and develop and implement mitigation strategies.
Ensure execution of the local Quality Management System.
Monitor, manage, and complete all applicable Quality deliverables in accordance with Global SOPs.
Provide guidance for the identification and timely implementation of appropriate corrective and preventive actions for deficiencies identified through audits and inspections.
Maintain the Quality Manual.
Participate in Management Reviews to confirm consistency and compliance with UCB procedures and local regulations, and to highlight adverse trends to management.
Participate in periodic Product Quality Reviews in accordance with MAH responsibility when required.
Establish and/or provide support to execute internal self-inspection and audit programs when required.
Support readiness and participation for all applicable cGxP external audits and regulatory inspections of UCB.
Provide Quality oversight to Local GxP Vendors in compliance with UCB Quality procedures, including qualification, quality agreements, monitoring through audit and/or periodic assessment, and divestment or discontinuation.
Approve any subcontracted activities impacting GDP or GMP at the Affiliate.
Ensure suppliers and customers of the Affiliate are qualified.
Collaborate with key GxP and business stakeholders to identify and assess quality risks, and support the local risk champion in risk mitigation activities.
Provide direction, formulate strategies, and make decisions to ensure efficient Quality operations and Quality risk mitigation.
Ensure product traceability as required.
Implement and/or execute compliant batch management and disposition processes including management of returned, rejected, recalled or falsified products and authorization of return to saleable stock for any returned medicinal products.
Participate in local recalls and all related correspondence with national competent authorities, and participate in Global recall activities when required.
Ensure compliance to GMP/GDP, and ensure proper shipping conditions are implemented as applicable, driving a QA decision on the disposition of the product in case of deviations (including excursions).

Requirements

Pharmacist qualification.
Business-level English proficiency (ability to speak and discuss in global meetings).
Over 5 years of experience in quality-related work.
Minimum of 5 years working in the pharmaceutical industry, in a quality management and/or Qualified Person position, having operational GMP experience.

Skills

Experience interacting with regulatory bodies or third-party organizations with respect to Quality systems and regulatory inspection preparedness.
Staff Management experience.
Practical experience and regulatory knowledge in manufacturing or quality control.
Communication skills to collaborate smoothly with stakeholders.
Ability to perform duties independently with initiative.

Location

Japan

Work Type

Full-time

Experience Level

5+ years

Education Level

Bachelor's Degree
Pharmacist

About the Company

UCB is a global biopharmaceutical company focusing on neurology and immunology.
Approximately 8,500 employees worldwide are inspired by patients and driven by science.
At UCB, we value creating value, not just completing tasks.
We aim to achieve results for patients by embracing challenges, collaborating, and pursuing innovation.
A culture of compassion and support is ingrained, where everyone is respected, accepted, and has equal opportunities to do their best.
We constantly aim for 'beyond,' delivering human-centered value to patients, employees, and the planet.
Working at UCB allows you to experience personal growth, build your career freely, and reach your full potential.

Equal Opportunity

UCB values equal opportunity. All hiring decisions are made regardless of any legally protected attribute.
If you require special consideration during the selection process to fully demonstrate your strengths and abilities, please contact EMEA-Reasonable_Accommodation@ucb.com. Please note that this contact point is only for consultations regarding special considerations in the selection process.