Senior Manager, Global Development Quality Lead Japan (GDQL-J)

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!

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
 

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.