Senior QMS Expert

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:

Overall job purpose：

Reporting to QMS Manager, As QMS Expert, provide expert for quality management system implementation and continuous leading improvement across the Quality and Site cross-functions.
To responsible of GMP compliance monitoring and management, Leading site Quality management system continuous improvement, including change control management, quality risk management, document management and global regulation implementation etc., to ensure the systems compliance with all Domestic and Global regulatory and corporate requirements.
Responsible for leading the continuous improvement projects of the Quality Management System (QMS) team, including proactively identifying discrepancies and risk points within the quality system, and actively and effectively promoting the ongoing optimization and improvement of the factory's quality management system to ensure the efficient and effective operation of the factory system.

Responsibilities：

Compliance (EHS/GMP/CUSTOMS):
Strictly follow regulation\SOP requirements, execute the operations with GMP common sense, fulfil Data Integrity requirements every time, all the time.
Point out the activities or issues which is not compliance, report to manager in timely manner.
Routine Operations R&R：
Leading quality system operation and continual improvement, including quality risk management, change control management, document management and etc., proactively identifying discrepancies and risk points within the quality system, and actively and effectively promoting the ongoing optimization and improvement of the factory's quality management system to ensure the efficient and effective operation of the factory system.
Lead, drive, and enhance the quality management system while supporting site regulatory compliance initiatives. You leverage resources from the QMS group to ensure timely deliverables and adherence to established targets. Additionally, you lead and drive quality initiatives that have a direct impact on site operations.
Lead on site quality index and performance monitoring and Quality Council organization to maintain the process of management review and report the quality index information to global team.
Lead and manage appropriate performance Site Quality Index and works with Site and Global stakeholders to successfully deliver the site deliverables, support to manage Site Quality Councils and the connection to Site quality performance for Global Quality Council while promoting suggestion and proposal for quality system enhancement and lead the improvement events.
Assist with regulatory compliance-related activities, including CMC dossier/variation preparation, compliance checks for submissions, and regulatory assessments to ensure product quality, safety, and compliance.
In charge of participation and implementation of self-inspection, internal audit and HA inspection activities. Ensures that audits are performed per developed schedule. Review findings and makes recommendations for findings. Ensures timely response and closure of all action items / commitments.
Strategy & Operational Improvement
In charge of continuously improve 6 GMP systems within site operation, to develop and certify the capability of system owner and sub-system owner, to cultivate and train SME， enhance quality culture maturity at site level.
People Development
Ensure individual development plan and implementation are in-place and meet the needs of increasing business.
Continuously improve GMP relevant process within site operation, develop individual continuous improvement awareness and capability.

 
Who you are:
BS in Pharmaceutical or equivalent.
At least 5 years’ experience in similar position areas of pharmaceutical plant.
Familiar with China GMP and regulatory requirements.
Fluent in English, both of written and oral
Result orientation, accuracy and reliability
Excellent communication, problem-solving, planning and organization skills
Project management experience is plus

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!