Job Detail

Req #: 1900008


Location: Boudry, Neuchatel, Switzerland


Job Category: Quality


Work Location: Route de Perreux 1 2017


Organization: Quality Operations


Employee Status: Full-time


Job Type: Regular

Department/Group:
Quality

Travel Required:
5%

Location:
Boudry, Switzerland

Position Type:
Full Time

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.
 
Job Responsibilities

• 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 

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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.