Vacancy expired!
DescriptionCelgene 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.PURPOSE AND SCOPE OF POSITIONThe Director, GMP/GDP Compliance position is responsible for design, development and implementation of global quality and compliance programs and processes within Celgene GMP/GDP functions. The position supports the continued operations and supply of quality products to the patient and plays a key role in addressing quality and compliance issues and risk.REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities Must have expert GMP, Quality, and risk management knowledge and experience. Musthave a comprehensive understanding of Good Manufacturing Practices (GMP) regulationsand guidance (ICH, CFR, PIC/S, EU, etc.) as related to pharmaceutical and biotechnologymanufacturing. Must be able to critically interpret problems and effectively communicate in a productivemanner to management, the group, and the broader organization with clarity and a highlevel of brevity and accuracy. Must be able to recognize and group technical/scientific attributes in potential situationsor issues and drive science based decisions across the function. Must share information about current interpretations and application of regulatoryexpectations between the decision-maker and other stakeholders. Must have expert authorship in technical documents. Must be able to critically interpretresults and generate technical conclusions consistent with quality risk principles. Must have expert authorship in investigations, and risk assessments. Must be able tocritically interpret results and determine the desirability of new or additional content forGMP policies and standards, etc. Must be skilled in planning and organizing, conflict management, coaching others, talentselection, developing others, decision-making, building relationships, innovationmanagement, and resource allocation. Must possess authenticity. Expert understanding of tools and approaches to assess and mitigate risk. Demonstrated project management skills with a proactive approach to issue identificationand resolution. Proficiency in developing presentations to facilitate meaningful discussions, with clearlycommunicated analysis, findings, and impact Coach and develop other team members. Ability to work effectively across functional groups and teams to ensure requirements aremet. Ability to make independent and objective decisions and to work with minimal supervision.DUTIES AND RESPONSIBILITIES Develop, implement and oversee Celgene’s quality risk management program per ICH Q9and other applicable industry guidance across GMP/GDP functions to support the continuedoversight and assurance of product quality and compliance.o Ensure appropriate application of GMP/GDP quality risk management principleswithin GMP/GDP operations including Quality, Development,Facilities/Equipment/Utilities, Materials Management; Production; Laboratories;Packaging/Labeling, Logistics and other applicable GMP/GDP operations.o Identify and deploy applicable quality risk management methods and toolsfacilitated by electronic systems and statistical tools as appropriate.o Develop and deliver training on the use of quality risk management methodsand tools to ensure consistency in application. Provide guidance and oversightto the organization regarding use of the methods and tools. Develop and implement processes for quality and compliance risk identification, assessment,control, review, tracking, communication, resolution and escalation as applicable.o Develop and implement applicable policies, standards, procedures and workpractices.o Develop and implement risk registers and associated processes.o Develop, implement and monitor applicable GMP/GDP quality andcompliance KPIs; implement processes for addressing identified trends. Establish processes to ensure GMP/GDP quality risk management information, assessments,data, etc. is available to all required stakeholders. Create and oversee execution of risk mitigation strategies and plans impacting quality andcompliance. Oversee quality risk management teams, provide direction, guidance and leadership toeffectively mitigate issues/risks. Lead the implementation of compliance activities within area of responsibility by guidingteams on accurate and timely responses to risks. Support health authority inspections, internal and external audits and diligence teams as asubject matter expert. Lead compliance and continuous improvement projects. Work in close collaboration with the other risk management functions to ensure consistencyin risk assessment, management, mitigation and continuous review. Other responsibilities as assigned by management.EDUCATION AND EXPERIENCE Relevant college or university degree required; advanced degree preferred. 10 years of relevant experience in a GMP regulated biotech and/or pharmaceuticalenvironment Minimum Travel required (<10%) #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.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDEAt 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.
Vacancy expired!