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:
Reporting to QMS Manager, Quality Management System (QMS) Supervisor hold QMS compliance group leader position and provide expert for quality management system implementation across the QMS and Site cross-functions.
In this role, you lead group, drive and enhance quality management system, support site regulatory compliance business. You leverage QMS compliance group resources to ensure on-time deliverables and adherence to defined targets. You support to drive Quality Initiatives that directly impact to the Site Operations.
You lead the development, establishment and enhancement of Quality systems, policies, processes, procedures and controls ensuring that performance conforms to established standards, including but not limited to documentation, training, change control, self-inspection, CAPA, global response team, external inspection Quality risk management etc.
You managed site GMP training and lessons learned programs, enhance quality risk management, establish proactive quality compliance system to successfully prevent and mitigate quality risks to Site Operations. You govern the artwork management and GMP Site License management to ensure compliance.
You support to 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.
You assist on regulatory compliance relevant activities, included CMC dossier/variation preparation, file compliance check, regulatory relevant assessment to ensure the product quality, safety and compliance.
You act as Delegated Quality Person in the site and bear responsibility for product releases according to related procedure and ensure that the production and testing of each product lot released conforms to all pertinent laws and regulations, pharmaceutical registration requirements and quality standards.
You are people manager who manage the individual performance within group, develop people and potentials, to meet the needs of increasing business.
Who you are:
BS in Natural Science (Pharmacy, Chemistry, Biology, or a related pharmaceutical science).
Five (5) years of experience within the quality operation of the pharmaceutical/health care industry
Familiar with China GMP and Chinese regulations and requirements.
Result orientation, accuracy and reliability as a must
Business fluent English
Excellent communication, problem-solving, planning and organization skills
Experience and knowledge in regulatory preferred
Project management and Six sigma Green Belt or Lean expert preferred
Functional Area: Quality
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!
and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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