Celgene Director QA Operations - Cell Therapy Manufacturing Facility 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.
Director QA Operations - Cell Therapy Manufacturing Facility
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Celgene is seeking a Director QA Operations at the Celgene Cell Therapy Manufacturing Facility in Summit NJ. This role will be responsible for leading the day-to-day Quality Assurance operations at the Summit Cell Therapy site including but not limited to drug product and materials disposition, Quality oversight of site engineering and validation activities, quality “on-the-floor” support to manufacturing operations, review and approval of site specific procedures and GMP documentation. This individual will be a key leader in the management team and a champion for quality principles and compliance within the Summit Cell Therapy organization.This role is stationed in Summit NJ and reports to the Head of Quality Summit Cell Therapy Manufacturing Facility.
Responsible for Quality Assurance oversight of GMP operations at the Summit NJ cell therapy manufacturing facility, and ensuring adherence to applicable GMP regulations and Celgene policies and procedures
Assure product quality and compliance by enforcing quality assurance policies and procedures; ensure the required processes, procedures, systems and resources are in place to enable a compliant disposition of materials and cell therapy products
Manage lot disposition activities and communicate lot disposition status; participate in Material Review Board meetings and evaluate recommendations made by the board during product disposition
Implement an effective “QA on-the-floor” program
Ensure timely QA support to the site operations and compliance activities, including but not limited to approval of GMP documentation, risk assessments, change control impact assessments, root cause analysis during deviation investigations, and development of corresponding CAPAs
Provide leadership and build an exceptional team to manage the Quality Assurance functions, including hiring, mentoring and developing personnel
Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of implemented GMP policies and quality management system; contribute to the global harmonization of processes and procedures across all cell therapy sites
Contribute to the development and execution of Celgene’s pre-license inspection readiness plan at the Summit facility
Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance at the Summit facility
Develop departmental goals and ensure timely completion of all deliverables
Champion and foster a positive and quality compliance culture
Establish and effectively manage the Summit Cell Therapy QA annual operating budget
Represent and lead Summit Cell Therapy Quality Assurance in the development of corporate initiatives and planning
Qualifications and Education Requirements
BS/MS in relevant Science or Engineering discipline and 10+ years of experience in managing Quality functions
Expertise in GMP compliance and global regulations
Experience with implementing and overseeing GMP operations in a commercial manufacturing facility is required
Demonstrated Quality leadership through a partnership approach with Operations to enable high quality and compliant product distribution to patients is required
Background in Biologics or Cell Therapy Manufacturing is required
Demonstrated experience building and leading exceptional Quality Assurance teams is required
Experience in continuous improvement, operational excellence and six-sigma is desired
Demonstrated excellence in written and verbal communication
Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment
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.