Senior Manager, Global Development Quality Lead Japan

We are looking for a passionate and experienced Senior Manager to join our Global Development Quality & Regulatory Compliance team as the Global Development Quality Lead for Japan (GDQL-J). In this key role, you will lead quality and compliance initiatives within our local affiliate operations, supporting GCP, GVP, Medical, and Regulatory Affairs. This position offers an exciting opportunity to create strategic partnerships, drive proactive, risk-based quality activities, and foster a culture of continuous improvement. If you are ready to make a meaningful impact and grow with us, we encourage you to apply.

A Typical Day:
In this dynamic role, you will:

• Lead GVP-compliant quality activities in collaboration with the business and GDQM team.
• Provide expert guidance on inspection readiness, preparation, and management at the local affiliate level.
• Partner with cross-functional teams to implement and sustain quality processes.
• Conduct audits and support issue management related to GVP, GCP, Regulatory, and Medical Affairs.
• Mentor, coach, and manage junior team members, fostering their professional growth.
• Collaborate with local and global stakeholders to align quality strategies and operations.
• Act as a subject matter expert in GCP and GVP, providing training and consultations.
• Drive process improvement initiatives to enhance efficiency and compliance.

This Role May Be For You If:
You are someone who:

• Thrives in a collaborative environment and builds strong stakeholder relationships.
• Has a proactive approach to quality management and risk assessment.
• Excels in managing complex quality issues and compliance activities.
• Enjoys mentoring and developing team members to achieve their full potential.
• Is detail-oriented and committed to maintaining the highest standards of quality.
• Values innovation and continuous learning to stay ahead in the pharmaceutical industry.
• Communicates effectively and influences peers and senior leaders alike.
• Is adept at managing multiple priorities and delivering results under tight deadlines.

To Be Considered:
Candidates must have a Bachelor’s degree and at least 8 years of relevant experience in the healthcare or pharmaceutical industry, with a strong background in quality management or clinical development. Advanced knowledge of GCP and GVP guidelines, along with experience in regulatory inspection management, is essential. Preferred qualifications include expertise in risk-based quality management and proficiency in Microsoft Office tools. Native level Japanese proficiency and business level English proficiency is required.

This is your chance to be part of a team that values integrity, innovation, and excellence. Join us in shaping the future of quality and compliance in the pharmaceutical industry. Apply today!