Celgene Senior Director, Quality Excellence in Boudry, Switzerland
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.
At least 10 years of experience in Quality Assurance and/or Quality Control in a pharmaceutical company or other related industry.
BS in Science, or related field.
Thorough understanding of cGMPs including EU, Swiss, and FDA regulatory requirements.
Excellent interpersonal, collaborative and organizational skills.
Ability to work independently, yet effectively in a team environment.
High credibility and reliability.
Excellent written & oral communication skills.
Skills in developing and improving process and Quality Management Systems at a strategic and an operational level.
Ability to focus attention to details.
Knowledge of most common office software and of IT-principles.
Duties and Responsibilities
Leads the continuous assessment of Quality processes of all Celgene Internal Manufacturing sites in close collaboration with the QA site Directors and the Operational Quality Systems and Affiliates Quality roles.
Leads specific Quality process improvement projects as assigned by the ED Global Internal Manufacturing (GIM) Quality.
Supports the QA site Directors to ensure an aligned process for the monthly site Quality Management Review Meetings.
Constantly monitors the external environment for Quality excellence trends (regulations, tools, concepts).
Represents GIM Quality in process improvement initiatives locally and globally as assigned by the ED GIM Quality.
Keeps a continuous exchange with the process excellence function of the Business Strategy & Integration department within GPDO as well as with the GIM Project Management and Process Excellence functions.
Aligns with MS&T and AS&T functions in relation to process excellence initiatives.
Supports face-to-face trainings of Quality staff in lean management.
Approves procedures and documents related to Celgene International Boudry and Celgene International II Couvet sites as part of the QA approver group.
Aligns Quality Systems strategies with the global Quality Systems group.
Continuously seek to improve existing processes and the development of new processes or related to the QMS.
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.
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