Celgene Head of Quality, Vector Plant 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.
Celgene is seeking a Head of Quality at the Vector Manufacturing facility in Boudry, Switzerland. This role will be responsible for leading the day-to-day Quality operations at the Vector Manufacturing facility including Quality Assurance Operations, Quality Systems and Compliance, and Quality Control. This individual will be a key leader in the Global Cell Therapy Quality organization and a champion for quality principles and compliance within the Vector Manufacturing organization. This individual will be a member of the Vector Manufacturing Leadership Team in addition to the Global Cell Therapy Quality Leadership Team. This role is stationed in Boudry, Switzerland and reports to the Vice President, Global Cell Therapy Quality.
Responsible for the Quality oversight of GMP operations at the Vector manufacturing facility, and ensuring adherence to applicable GMP regulations and Celgene policies and procedures
Assure the required processes, procedures, systems and resources are in place to ensure a compliant disposition of materials and vector products
Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of GMP policies and quality management system
Provide leadership and build an exceptional team to manage the Quality functions (Quality Assurance, Quality Systems, Quality Control), including hiring, mentoring and developing personnel
Work collaboratively with Leads from Facilities and Engineering, Manufacturing, IT, MS&T, to ensure a timely Vector facility qualification and operational readiness for commercialization
Lead the management review of quality compliance and operational KPIs at the Vector manufacturing facility; ensure timely mitigation of unfavorable trends
Lead the implementation of Celgene’s Pre-license inspection readiness plan at the Vector Manufacturing facility
Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance at the Vector Manufacturing facility
Lead and host compliance audits and regulatory inspections by competent regulatory authority (e.g., FDA, EMEA, PMDA, etc.)
Develop departmental goals and ensure timely completion of all deliverables
Champion and foster a positive and quality compliance culture
Establish and effectively manage the annual Quality operating budget
Lead and represent Vector Manufacturing Quality in the development of corporate initiatives and planning
Qualifications and Education Requirements
BS/MS in relevant Science or Engineering discipline and 15+ years of experience in managing Quality functions
Expertise in GMP compliance and global regulations
Experience in hosting global regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory agency reviewers is required
Experience with implementing and overseeing GMP operations in a commercial manufacturing facility is required
Demonstrated Quality leadership through a partnership approach with manufacturing to enable high quality and compliant product distribution is required
Background in Biologics Manufacturing is required
Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems and Quality Control 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
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