Celgene Mgr, Global Quality Systems in Summit, New Jersey
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.
Manager, Global Quality Systems
Associate Director, Global Quality Systems
Prerequisites (As Applicable)
Relevant college or university degree; 5-7 years’ relevant work experience; minimum 5 years of project or people leadership experience; equivalent combination of education and experience acceptable.
Summit, New Jersey
PURPOSE AND SCOPE OF POSITION:
This position is responsible for Quality oversight of Celgene Enterprise GMP/GDP IT Systems. The position has accountability for decisions regarding applicable system compliance including design, implementation and continuous improvement and is responsible for development of applicable processes and procedures.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
Extensive experience with design, implementation and continuous improvement of electronic technology solutions;
Ability to serve as enterprise wide subject matter expert in the area of quality and compliance requirements for IT systems;
In-depth knowledge of international regulatory directives (FDA, EMA, MHRA, PMDA, QSR, ICH, PIC/S) and Risk Management principles with the ability to interpret and apply requirements;
Strong customer focus, both internally and externally and must be able to build/maintain relationships with key stakeholders;
Proven ability to work effectively with cross-functional stakeholders in a complex, changing global environment;
Able to communicate effectively within the job function and with internal and external cross functional teams;
Ability to work proactively and independently with the ability to make decisions within the subject matter area;
Demonstrated negotiating and interaction skills in internal and external cross-functional teams;
Demonstrated critical reasoning, problem-solving and decision-making skills;
Demonstrated resource management and planning skills;
Demonstrated oral and written communication skills including presentations to senior management and external organizations.
Prior experience with relevant systems such as document management, ERP, training management and lab systems
DUTIES AND RESPONSIBILITIES:
Provide Quality Oversight for Celgene Enterprise GMP/GDP IT Systems:
Review and approve IT Validation deliverables – User Requirements, Requirements Traceability Matrices, Risk Assessments, Validation/Test Plans, Installation Qualification, System Testing, User Acceptance Testing, Validation/Test Summary Reports, Disaster Recovery Plans/Reports, Retirement Plans/Reports;
Perform Quality Gate Reviews for system implementations and enhancement releases.
Review and approve deviations and/or Corrective Actions/Preventive Actions (CAPAs);
Evaluate and approve IT Change Management documentation; authorize IT systems for use upon verification that requirements are met;
Review and approve IT procedures [Policies, Standard Operating Procedures (SOPs), Work Practices (WPs), Guidelines] and training courseware as applicable;
Ensure processes and procedures are compliant with relevant cGMPs;
Ensure continuous improvement of governing processes and technology solutions through periodic enhancements and upgrades;
Communicate effectively with all cross functional and regional stakeholders on matters related to job responsibilities;
Assist in audits of suppliers/vendors of IT systems;
Support internal and health authority inspections;
Provide back-up support for department as needed;
Perform other assignments as required.
EDUCATION AND EXPERIENCE:
Relevant college or university degree.
5-7 years’ relevant work experience; minimum 5 years of project or people leadership experience; equivalent combination of education and experience acceptable.
WORKING CONDITIONS: (US Only)
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
DEFINITIONS AND ABBREVIATIONS (As Applicable)
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.