Bristol-Myers Squibb is a global Biopharma company committed to a single mission : to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
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Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Duties and Responsibilities Acts as Quality Responsible Person of Celgene China and is herewith responsible for the GMP / GDP compliance and alignment of quality standards with Celgene applicable policies.
Ensures proper maintenance and implementation of Celgene China Quality Management System : Supervises correct drafting, issuing and storage of documents.
Establish and manage local Standard Operating Procedures for relevant processes Responsible for ensuring continuous and initial training programs are implemented and maintained.
Manages Product Quality Complaints (PQCs), product returns & destruction and product recalls in accordance with Celgene's applicable procedures and GDPs.
Manages QA Compliance activities at the Affiliate in relation to deviations, CAPA, and Change Controls. Liaises with Celgene Logistics and oversees Contract Service Providers to ensure GDP compliance of storage, transport and distribution activities as per Technical and Quality Agreement in place.
Responsible for preparing and hosting of internal Corporate audits and GMP / GDP Health Authority Inspections. Coordinate with the Global Compliance GxP Audit (GMP / GDP, GPV, GCP) and Inspection Group.
Responsible that self-inspection in China affiliate is performed regularly. Knows about the policy of security at work and about laws concerning health and security of the workers.
Have oversight of Quality activities for Celgene Marketing partner Beigene Acts as Quality Responsible Person of Celgene China for Pharmacovigilance in China affiliate and support PV team to maintain affiliate PV QMS for pharmacovigilance activity in relation to SOP Management, Training, deviations, CAPA, and Change Controls.
Support clinical activities and Celgene Global CQA to meet GCP requirement if needed. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment.
We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Company : Bristol-Myers Squibb Req Number : R1526053 SCN Updated : 2020-05-29 00 : 00 : 00.000 UTC Location : Beijing,China Bristol Myers Squibb is an equal opportunity employer.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.