Sr. Manager, Quality Assurance

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