Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
As a key member of the CQA Audit and Inspection team, this position is responsible for leadership, planning, conduct, and reporting of GCP audits in order to ensure that clinical trials are conducted in compliance with applicable international regulations, guidelines, and global company standards. This role also has responsibility for preparation, management, and follow-up of global Health Authority (HA) GCP inspections, and provision of quality oversight and consultation at the clinical study or program team level in support of proactive quality management. This individual actively leverages audit / inspection outcomes / trends to effect improvement in clinical trial quality and compliance with Celgene and global regulatory requirements. Responsibilities also include leading and/or contributing to identification, development, implementation, management, and enhancement of CQA operational processes, systems, tools, and best practices.
Functional Scientific/ Technical Skills
Level of Independance:
Creativity and problem solving:
Education and Experience:
#LI-POSTCelgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.