质量系统经理

Work Your Magic with us!  

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your role:

Responsible for building, implementing and maintaining a high-level of Quality Management System and operational compliance to ensure that external manufactured products are available and meet applicable regulatory requirements in China as well as company’s quality and safety standards.

• Develop and maintain a robust quality management system to ensure that external manufacturing operations in China region fully compliance with current GMP and dynamic MAH-related regulations.
• Regularly monitor, review, assess and report on the pharmaceutical quality system and quality performance to maintain a high level of effective compliance within quality management system.
• Lead quality risk management initiative for external manufacturing quality management.
• Oversee personnel training management to ensure compliance with GMP and MAH regulations.
• Ensure the proper maintenance of Drug Manufacturing Licenses to ensure the smooth operation of external manufacturing activities.
• Manage HCQ/ESQ audits, Health Authority inspections, and GMP self-inspections within EMQ China.
• Support projects related to external manufacturing from perspective of quality system management, ensuring GMP compliance and adherence to quality standards.
• Collaborate directly with internal and external stakeholders to ensure sustained quality and compliance.
• Perform additional tasks assigned by company as necessary.
• Recognizes responsibility for output of own specialization and takes accountability, promotes giving ownership and guidance to less experienced colleagues.
• Directs the personal performance and development to support functional goals.
• Collaborates with broad cross-functional teams to support Healthcare products manufactured in CMOs
• Interacts with local health authorities (JSDA, NT inspection Branch and CMO located provincial MPA)
• Interacts with external business partners (CMOs)

Who you are:

• Pharmacist with bachelor’s degree or above
• Require a degree (e.g. pharmacist, chemist, engineer) that provides knowledge of theories, principles and concepts within Quality Management System
• Require professional experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences (approximately 10 years as guide)
• Requires extensive knowledge on a broad scope of quality and drug registration and/or post-approval change regulations, good understanding of external compliance trends and ability to address needs based on external demand.
• Excellent communication skills: ability to influence key stakeholders, strong negotiate skills and ability to develop creative ideas for conflict resolution.
• Strong knowledge of technical writing and project management skills
• Excellent organization and presentation skills
• Business-fluent Mandarin and English, both verbally and in writing.

• Minimum 10 years of experience in pharmaceutical / biopharmaceutical industry, medical, or life sciences required, at least 3 years working experience in quality system management.
• Demonstrated ability to work across matrix organization in international and multi-cultural environment
• Good understanding of external compliance trends and ability to address needs based on external demand
• Preferred Experience:

• Experience collaborating with external partners (e.g., contract manufacturing organizations, contract laboratories, and suppliers).
• Experience in application and maintenance of Drug Manufacturing License (B)
• Experience in Health Authority readiness and host

• Familiarity with quality management electronic systems, as a Subject Matter Expert (SME)

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!