Celgene Manager/ Associate Manager Quality Projects & Regulatory in Porto Salvo, Portugal
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.
Under the direction of Regulatory Affairs & Quality Director, this individual will coordinate regulatory and quality activities in Portugal, in order to ensure the appliance of national regulatory and quality legislation and Corporate policies, and will collaborate in other department projects in the Spain and Portugal region.
Responsibilities include, but are not limited to:
Acts as Technical Director of Celgene Portugal and is herewith responsible for the GDP compliance and alignment of quality standards with Celgene applicable policies.
Ensures proper maintenance and implementation of local Quality Management System: Supervises correct drafting, issuing and storage of documents. Assist all departments in the preparation, writing and follow up of Standard Operation Procedures (SOPs).
Responsible for ensuring continuous and initial training programs are implemented and maintained, in line with Corporate policies.
Manages Product Quality Complaints (PQCs), inventories, local release, product returns and product recalls in accordance with Celgene’s applicable procedures and GDPs.
Liaises with Celgene Logistics and oversees Contract Service Providers to ensure GDP compliance of storage, transport and distribution activities as per Technical and Quality Agreement in place.
Responsible for preparing and hosting of internal Corporate audits and GMP/GDP Health Authority Inspections. liaising as needed with the Global Compliance GxP Audit and Inspection Group.
Ensure local self-inspections are performed regularly.
Participates and collaborates with the Quality international team as well as working groups.
Keeps Management updated through the Quality Review Reports on Quality Management System performance and any opportunity for improvement.
Ensure local support to the Headquarters in the preparation and management of new Centralised MAA, variations and other post-authorisation submissions.
Coordinate and provide linguistic review of Product Information. Review/approve & maintenance of artworks including the local requirements (blue box). Maintain up to date local product information and SmPCs.
Responsible for submission of new clinical trials and post-authorisation studies applications and amendments to Infarmed, and support IITs from a regulatory perspective. Act as the contact with Infarmed and any other local Health Authorities.
Regulatory approval of all local promotional materials and other non-promotional materials, as needed, ensuring internal review is duly performed and complies with local requirements. Submission of promotional materials to local Health Authorities.
Provide regulatory support in the local assessment and approval of Compassionate Use requests.
Review required technical and quality information for the tendering and orders processes.
Contribute to the Regulatory Intelligence information flow, by gathering, analyzing and communicating the defined information to interested parties, at an internal level.
Support the implementation and maintenance of the Environmental Management System ensuring relevant communications to Competent Authorities in compliance with current regulation.
Collaborates in any additional regional project if required.
Compliance with Quality and Environment Policies and Ethical & Celgene Policies.
Educational Background and Complementary Knowledge
University degree in science or medically related, a degree in pharmacy is mandatory.
Appropriate competence and knowledge of Quality, GDP and Regulatory Procedures.
Computer Literature: Good Knowledge at user level of Microsoft Office.
Fluent in written and spoken English.
5-7 years of working experience in quality and regulatory function in the pharmaceutical industry, with at least 3 years as Technical Director in Portugal.
Expert level of applicable Regulatory requirements and enforcement.
Creates global mindset and drives execution.
Demonstrated ability to work and integrate across functional areas; fosters teamwork.
Interpersonal and communication skills.
Effective planning and priority setting skills; committed to meet goals and agreed timelines.
Ability to develop effective, flexible relationships with others; understands the perspectives of others.
Expert level of applicable Regulatory requirements and enforcement.
Strong identification with Celgene’s values and general Quality and Regulatory principles.
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