Sr. Manager, Quality Assurance (Minato-ku, Tokyo-To, JP)

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

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