Job Detail

Req #: 1900119


Location: Boudry, Neuchatel, Switzerland


Job Category: Quality


Work Location: Route de Perreux 1 2017


Organization: Quality Operations


Employee Status: Full-time


Job Type: Regular

What great looks like in this role:
Our ideal Director of Quality Assurance Operations in support of CAR T is experienced in managing quality assurance functions in a commercial manufacturing facility with expertise in GMP compliance and EU regulations. You’ll use your skills to lead and manage the technology transfer and routine GMP operations at contract manufacturing organizations (CMO) in support of cell therapy.

Objectives of this Role:

• Provide quality oversight of technology transfer and routine GMP operations at CMOs in support of cell therapy intermediate product manufacturing (referred to as Day 0/Make 1).


• Partner with CMO Quality and oversee execution of corresponding Chemistry, Manufacturing, and Controls (CMC) studies in support of investigational medicinal product document (IMPD) and Marketing Authorization Application (MAA) submissions.


• Provide quality compliance guidance and oversee readiness for pre-license inspection including the remediation of any GMP deficiencies in order to ensure a timely approval and commercial launch.


• Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of CMO oversight program.

Daily and Monthly Responsibilities:

• Responsible for batch record review and Day 0/Make 1 product disposition.


• Responsible for review and approval of CMO deviation investigations, CAPA, controlled documents.


• Act as QA impact assessor and approver of CMO related changes.


• Responsible for data auditing, review and approval of protocol and reports in support of IMPD/MAA submissions.


• Develop and approve annual product review reports generated by CMOs.


• Collaborate with Global Quality Systems and ensure CMO’s timely implementation of corrective actions resulted from Celgene’s audits.


• Partner and provide support to the Qualified Person (QP) with respect to finished drug product disposition and distribution in EU.


• Support Management Review activities and oversee trending of key quality, product and GMP metrics related to CMO.


• Participate in Material Review Board meetings and evaluate recommendations made by the board during product disposition.


• Mentor and enable individual development of direct reports.


• Develop departmental goals and ensure timely completion of all deliverables.


• Establish and effectively manage the annual operating budget for the QA Operations team in EU.


• Represent the Global Cell Therapy Quality in regional committees and forums.


• Assist in CMO GMP audits, as required.

Knowledge and skills required: 

• Bachelor’s degree with a minimum of 10 years of biotech or pharma industry experience.


• At least five years’ experience managing Quality Assurance functions in a commercial manufacturing facility.


• Expertise in GMP compliance and EU regulations is required.


• Background in Biologics or Cell Therapy Manufacturing is required.


• Demonstrated experience building and leading exceptional Quality Assurance teams is required.


• 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.


• Ability to speak English, as business language, is required

Preferred qualifications:

• Experience with overseeing GMP operations in a commercial CMO manufacturing facility is preferred.


• Experience in continuous improvement, operational excellence and six-sigma is desired

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About Us




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.