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Job ID: 13051
Location: Basking Ridge, NJ -110
Full/Part Time: Full-Time
Category: Manufacturing/Tech Ops
Department: Investigator Mat. Supply Chain - 3611
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.
BA/BS Life sciences / computer science / Management Information
Systems PLUS 7+ years clinical technologies validation experience OR Equivalent. Preferred experience with IVRS and electronic management of clinical supplies distribution.
This position is mainly responsible for the development and implementation of the Quality Assurance (QA) and User acceptance Program (UAR) for IVR and IMSC systems in support of clinical trials. The incumbent will provide leadership and have final responsibility for all QA and test activities within assigned application areas that support key business processes and initiatives. This will require managing multiple concurrent projects on different application systems.
Responsibilities include, but are not limited to, the following:
- Develop the Quality Management Plans and Test Strategies for all IMSC projects assigned
- Responsible for User Acceptance Test (UAT) approach, documentation and management
- Responsible for determining acceptance criteria of systems
- Define the UAT structure for developing, organizing and maintaining test cases
- Maintain all Test Assets generated by a project. Assist the IMSC IVRS Central management Team in developing and coordinating UAT plan for each system
- Review and Approve all project Test Deliverables and design specs
- Collect, analyze and report on quality metrics for all projects, and vendors
- Establish and maintain a quality monitoring plan for live systems
- Participate as needed on the IMSC IVRS Central management Team to ensure that members understand the quality management plan, test strategy, and quality processes
- Provide training on UAT processes and associated tools when necessary
- Gain sponsorship buy-in for quality initiatives such as promoting ongoing training and implementing best practices throughout the project
- Ensure sufficient infrastructure to support quality initiatives
- Assist with the development of Quality Assurance and UAT Standards, Processes, Procedures, Methodologies, and Practices to support IMSC areas of responsibility
- Collaborate and assist in management of vendor activities.
- Independently makes decision to ensure the effective resolution of issues as they develop
- BA/BS Life Sciences / Computer Science or related technical area / Management Information Systems PLUS 7 + years clinical technologies experience with direct experience with IVRS validation OR Equivalent. Preferred experience with IVRS (validation and design) and clinical supplies chain management
- Demonstrated skills in management of multiple projects simultaneously.
- Familiarity with legislative and regulatory requirements with respect to investigational drugs.
- Knowledge of use case methodology
- Demonstrated excellent teamwork and collaboration skills
- Ability to lead and motivate employees
- Knowledge of the software validation process in an FDA regulated environment
- Knowledge and ability to apply FDA 21 CFR Part 11requirements
Celgene 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.
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee's temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.