Sr. Manager Inspection Readiness

Req #: 1804640
Location: Bothell, Washington, United States
Job Category: Quality
Work Location: 1522 217th Pl SE 98021
Organization: Quality Operations
Employee Status: Full-time
Job Type: Regular

Primary responsibilities include:

• Coordinate end to end inspection readiness activities, including preparation and strategy sessions, interaction training for subject matter experts, and managing logistics
• Schedule and conduct mock interviews for subject matter experts (SMEs)
• Lead activities to coordinate creation, review, approval and submission of responses for inspection and/or audit findings
• Monitor and report on remediation actions resulting from audit / inspection findings and drive through to completion
• Implement and maintain the self-inspection program including annual planning of audit events, auditor certification, and performance of self-inspections in accordance to the annual schedule
• Publish and report inspection data trends in accordance to Quality Management Review requirements
• Review, analyze and distribute regulatory inspection data issued by regulatory authorities (FDA, EMA, PDMA) to ensure proactive compliance across the organization
• Develop and manage an annual inspection preparation plan for the site
• Manage IT tools which support the Inspection Readiness activities for health authority inspections

Required Qualifications

• 7+ year's Quality or Manufacturing experience with a significant part of that time developing compliance and/or auditing programs in a cGMP/FDA regulated environment
• Familiar with all phases of biologic or small molecule drug development.
• Experience with GCP/GLP/GMP auditing practices
• Experience interacting with health authorities during inspections
• Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
• Strong knowledge of federal regulations and other applicable standards
• Project management experience with a track record of meeting goals and objectives
• Proven technical writing skill set
• Proven experience working as a detailed oriented team player with effective planning, organization and execution skills.
• Innovative, proactive, and resourceful; committed to quality and continuous improvement.
• Strong interpersonal and leadership skills.
• Able to manage multiple priorities.
• Strong computer skills with MS Office (e.g. Word, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)

Educational Requirements:

• Bachelor's degree

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.

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.