About this role
Purpose of the job: The aim of the position is to ensure adequate local Quality Managing System and to act as the official Qualified Person Delegate in Lundbeck Japan. Responsibilities: • The Quality Assurance Senior Manager interacts with partners to accomplish Quality Technical Agreement (QTA) activities and provide QA support to Supply Chain Management (SCM) related activities. • Implement and maintain product quality management system (QMS) for GMP/GDP incl. related standard operating procedures (SOP’s) to fulfil Japan MAH responsibility. • Provide relevant quality department with information of GMP/GDP inspections of the subsidiary performed by the authorities. • Establishing quality agreements with contract warehouses and service contracts with external companies. • Plan for and conduct self-inspection. • Managing of training. • Documentation and record control. • Change Control • Managing of APQR (Annual Product Quality Report Review) • Contribute to other quality control related tasks. • Communication between global Quality teams and external suppliers for quality matters. • Participate in assigned ad-hoc cross-functional projects and interfaces with R&D, Manufacturing, Supply, Distribution, Quality, and Regulatory colleagues. • Maintain approved dossier in collaboration with RA CMC. Tasks: • Provide relevant quality department with information of GMP/GDP inspections of the subsidiary performed by the authorities. • Ensure proper product release to the market. • Establishing/Maintaining quality agreements with contract warehouses and service contracts with external companies. • Handling complaints and recalls in cooperation with relevant quality department. • Managing Lundbeck falsified cases. Experiences: • Minimum 15+ year of pharmaceutical experience in Quality, Compliance, and/or regulatory setting • Previous experience working with liaising with PMDA, Tokyo Metropolitan Government, and/or MHLW • CMO oversite, risk and project management • Previous experience with leading teams and/or managed peopl Competencies: • English skill (verbal and written) • Excellent communication and presentation skills in both Japanese and English • Foster strong cross-functional collaboration and shared accountability across local and global teams to successfully deliver quality objectives • Knowledge of GMP compliance inspection for JNDA • Knowledge of JP, EU GMP and ICH guideline • Overall knowledge for SCM related activities, especially cold chain products • Technical knowledge of Biologics CMC, GQP, GMP and pharmaceutical-related laws and regulations • Strong analytical and problem-solving skills with ability to prioritize multiple tasks • Being accountable: Driving results with a focus on achieving milestones. Action-oriented taking initiative to move activities forward. Demonstrated ability to influence peers, management, and external colleagues, proactively and effectively. • Being adaptable: Demonstrate flexibility and diplomacy in dealing with ambiguity. Systematically learning from success and failures. • Being curious: Actively exploring diverse perspectives and challenging the status quo