Director, Clinical Quality Management - Continuous Improvement
Other Locations:US- NJ- Berkeley Heights- 400
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 will be responsible to drive establishment of a clinical quality management system framework that supports senior leadership decision-making and prioritization/management of improvement projects related to risks identified across resources, processes and technologies used in clinical trials. This position involves building a team, governance and management forums as well as associated processes and tools that supports the organization and individuals study teams with assessing and measuring risks to quality and timelines and improvement project teams with implementing preventive actions that support operational excellence. The person in this position must have strong leadership and influencing skills and at least 10 years of experience with organizational transformation projects.
This position reports directly to the Senior Director, Clinical Quality Management.
- Develop and manage a plan for establishing a clinical quality management system framework that supports effective management of people, processes and risks and enables access to knowledge that may prompt improvements
- Lead a group of cross-functional colleagues in assessing risks to quality and developing action plans and work with cross-functional leadership to develop, prioritize and implement improvements needed to reduce/mitigate risk
- Establish a Process Owner Network to support efficient processes and assessing impact of change to the people within the quality system
- Establish a capability for analyzing process improvements / change needed and determining highest priority areas for support, resulting in best-fit resource utilization
- Establish and manage metrics related to risks that facilitate continuous improvement; Design and implement a measurement system that supports performance assessment used to identify process improvements
- Establish support for cross-functional colleagues in the development of responses for internal system audits and regulatory inspections that address identification of actual root cause and improvements needed
- Support business process owners with improvements and identification of effective QC measures for monitoring process adequacy and compliance
- Support development of a strategy map resulting in greater alignment between initiatives and strategy
- Minimum 10 years leading or managing transformational improvement projects in the pharmaceutical or biotech industry
- Strong knowledge of quality systems concepts and direct experience working in a GxP environment; Experience in GCP auditing is a plus
- Strong leadership, communication and presentation skills and experience working with global teams
- Knowledge in risk assessment, root cause analysis and the use of metrics to identify risks is desired; Six Sigma training is a plus
#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.