Associate Director QA Operations, Global Cell Therapy

Req #: 1901104
Location: Offsite, Germany
Job Category: Quality
Work Location: OFFSITE
Organization: Quality Operations
Employee Status: Full-time
Job Type: Regular

At Celgene, we're committed to changing the course of human health through bold pursuits in science, life-enhancing therapies and a promise to always put patients first. At the core of that mission are the talented individuals on our Global Cell Therapy Quality team who collaborate globally and cross-functionally to drive innovation.

Join our team as an Associate Director, QA Operations - Global Cell Therapy, and help us deliver truly innovative and life-changing medications to our patients worldwide.

What great looks like in this Role:

Our ideal Associate Director, QA Operations - Global Cell Therapy is responsible for partnering and providing support to the Qualified Person (QP) with respect to drug product disposition and distribution in the EU. You will be a key leader within the Global QA Supply Chain organization, and represent the Cell Therapy Quality organization in regional committees and forums. If you're up for the challenge, apply today!

Responsibilities of this Role:

• You will..
  • Provide Quality oversight of routine operations at CMOs in support of cell therapy intermediate product manufacturing
  • Partner with CMO Quality to provide oversight of manufacturing operations and ensure work is performed in accordance with approved regulatory submissions and applicable regulatory requirements
  • Provide quality compliance guidance and oversee readiness for pre-license inspection including the remediation of any GCTP/GMP deficiencies 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
  • Responsible for batch record review internal (Celgene) Day 0/Make 1 intermediate 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/reports in support of regulatory 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
  • Assist in CMO GCTP/GMP audits, as required
  • 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

Knowledge and Skills Required:

• Bachelor's degree with a minimum of 10 years of biotech/pharma industry experience; a minimum of 5 years of managing Quality Assurance functions in a commercial manufacturing facility
• Expertise in GMP compliance and EU regulations is required;
• Experience with overseeing GMP operations in a commercial CMO manufacturing facility is preferred
• 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;
• Ability to speak English, as business language, is required

About Us

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.

#LI-POST

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.