Celgene Sr Mgr, GMP Corporate Audit 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.
In addition to line-based QC/QA activities, Celgene implements a corporate audit/inspection program through the Corporate Audit and Inspection Group (CAI) which is accountable to the Chief Compliance Officer. This program provides important independent feedback directly to corporate executives about the effectiveness of highly critical business processes and the associated business unit QA functions and controls. CAI exists as a tool for executive management. Our role is focused on providing timely and independent GxP, HCC, CSV, and EHS related compliance feedback to management and assuring a uniform, professional, best-in-class process for management of regulatory health authority & government inspections/investigations in accordance with the company’s GxP, Health Care Compliance, and EH&S Inspection Policy. The CAI group is committed to providing a trusted, value-added process that is supported by an understanding of key business areas and processes. Our stakeholders benefit from our independence and the corporation views our role as critical to the confirmation of its compliance posture.
Under the direction of the Sr. Director, GxP & EHS Corporate Audit, this individual will be responsible for assisting with the associated related activities that will provide primarily Good Manufacturing Practice.
Responsibilities include, but are not limited to:
Independently plan/ lead/participate/report on internal/external GMP audits of Celgene and its partners, identifying GMP compliance gaps or risks.
Provide GMP compliance consultation and expertise to internal and external customers.
Perform tasks and work to achieve company goals and organizational objectives.
Lead audits of global processes in support of Celgene’s pharmaceutical/biotech/CAR-T products.
Conduct “mock” pre-approval inspection readiness assessments; advise and support the sites in executing remediation actions to ensure compliance to regulatory and Celgene expectations.
Participate in development of periodic compliance reviews for analysis and trending of GMP audit and inspection findings to stakeholders.
Maintain audit database for observations and audit CAPA.
Contribute to the development and implementation of Standard Operating Procedures.
Serve as a subject matter expert within the GMP discipline.
Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Assist in the development of the annual audit plan (where applicable).
Develop and deliver GMP Compliance training and participate with training and development of junior staff.
A thorough knowledge of the drug development process, pharmaceutical/biotech/CAR-T manufacturing and testing, quality systems, compliance regulations (national and international), scientific terminology, company quality assurance procedures and policies, the use of the computer and software developmental methodologies, and quality auditing/evaluation techniques.
Ability to analyze emerging compliance issues and recommend strategies to manage compliance risks.
Advanced subject matter expert in global GMP regulations and guidance’s.
Basic Knowledge in global GMP Regulations and guidance.
Detailed oriented, excellent written, oral communication, organization, investigation, and negotiation skills, and be diplomatic.
Previous direct manufacturing/QA experience with CAR-T/Biologics products is preferred
Position require about 25% domestic and international travel.
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.