Senior Quality Specialist

Title: Senior Quality Specialist

Location: Japan HQ

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About the job

As Senior Quality Specialist (Expert Japan) within our Vaccine R&D Quality Operations team, you'll lead all quality-related activities for Vaccine R&D in Japan, ensuring compliance with local and global quality standards while supporting timely product launches. Ready to get started?

Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you'll help advance prevention on a global scale — and shape the future of immunization.

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About Sanofi

We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

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Main responsibilities

Inspection Readiness & Regulatory Compliance

• Act as local Quality Leader for inspection readiness and product launch readiness in Japan

• Develop and execute comprehensive readiness plans for new product launches, including coordination with cross-functional teams

• Review relevant sections of submission dossiers to ensure quality and compliance with Japanese regulatory requirements (PMDA, MHLW)

• Support liaison with Japanese regulatory authorities during inspections and pre-approval testing, and contribute to response strategies for any findings

Third Party Management & Auditing

• Plan and conduct audits of local manufacturing, distribution, and laboratory operations to ensure compliance with applicable standards

• Provide quality oversight for local clinical contract manufacturers, including creation or review of quality agreements

• Identify gaps and drive corrective and preventive actions for continuous improvement

Investigational Product Management

• Oversee the release of investigational medicinal products and components in line with local regulatory responsibilities

• Ensure compliance with relevant regulations for investigational products used in clinical development

Quality Systems & Stakeholder Collaboration

• Maintain and continuously improve quality management systems in alignment with global and local standards, ensuring robust documentation and data integrity

• Interface with R&D management locally and globally, collaborating with quality, regulatory affairs, CMC, and pre-clinical safety teams to align on launch timelines and inspection strategies

• Provide training and guidance to site personnel on inspection readiness, auditing practices, and regulatory expectations

​Role Context & Scope

Role Impact:

• Interacts with local functions in Japan, including pre-clinical safety, CMC, and regulatory affairs to provide input and advice

• Accountable for quality of CTDs and submission dossiers

• Decision maker for audit and third-party oversight

Scope:

• Compliance to GLP, GMP, and GDP processes in Japan R&D

• Vaccine R&D QO Auditor for local operations

• Vaccine R&D local IMP Release for Japan

• Vaccine R&D QO Documentation Owner

• Vaccine R&D QO Third Parties Coordination

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About you

• Education: Bachelor's degree in Pharmacy, Chemistry, Biology, or a related field (advanced degree preferred); knowledge in Quality Assurance, Compliance, and applicable regulations

• Experience: Extensive experience in pharmaceutical quality assurance, with a proven track record managing regulatory inspections — preferably pre-approval inspections — and providing oversight of clinical contract manufacturers

• Technical expertise: Strong knowledge of Japanese GMP/GQP, GDP, GLP, and global regulatory standards; experience in auditing operations and understanding of clinical development CMC and GMP/GLP requirements; experience with product launches in Japan is an advantage

• Languages: Native level Japanese and strong business level English required

• Skills: Strong networking, negotiation, and communication abilities; able to work effectively in cross-functional teams and manage complex projects under tight timelines

• Leadership: Ability to engage with all levels of the organisation, drive cross-functional collaboration across global and local teams, and demonstrate agility in responding to evolving regulatory requirements

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Why choose us?

• Work at the forefront of AI-driven research, smart manufacturing, and groundbreaking mRNA platforms that are redefining the future of immunology

• Help protect half a billion people every year, contributing to one of the largest global vaccination efforts in healthcare

• Play a critical role in ensuring product launch readiness and regulatory compliance for life-saving vaccines in Japan

• Develop your career with access to mentoring, international mobility programs, and opportunities to grow across four continents

• Share knowledge with leading scientists, engineers, and quality experts in a purpose-driven community dedicated to protecting millions worldwide

• Join a workplace where diversity, equity, and inclusion are at the core, with Employee Resource Groups and leadership programs that celebrate every voice

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Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science — where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what's never-been-done-before. You'll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people's lives? Let's Pursue Progress and Discover Extraordinary — together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.