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.
The individual in this position supports functional process owners in the identification and assessment of risks to clinical trial quality and development and maintenance of standards, procedures, audit/inspection responses and business requirements/configurations that support continuous improvement of all processes/systems that are a risk to clinical trial quality. He/she will be responsible to develop a Quality Oversight Plan that supports identification and remediation of process gaps, assessment of ongoing issues (trends) and prospective quality checks. He/she will lead a Quality Oversight Forum in review of quality metrics, identification of process improvements needed to reduce risks to quality and CAPAs related to sponsor responsibilities in ICH E6.
Prior experience with GCP auditing and leading or participating in regulatory inspections is required. Knowledge in risk assessment, root cause analysis and prospective indicators of quality issues is desired.
This position reports directly to the Senior Director, Clinical Quality Management.
#POST-LICelgene 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.