Principal Specialist Risk Management

Req #: 1900341
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

QA Principal Specialist, Risk Management
Bothell, Washington

Job Description:
At Juno Manufacturing Plant (JuMP), a Celgene Corporation company, 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 Quality Risk Management (QRT) team who collaborate globally and cross-functionally to drive innovation.

Join our team as a QA Principal Specialist, Risk Management and help us deliver truly innovative and life-changing medications to our patients worldwide.

What great looks like in this Role:

Our ideal QA Principal Specialist is responsible for supporting the Quality Risk Management Program by facilitating risk assessments, implementing risk mitigation measures for JuMP operations, and employing a methodical approach to applying risk assessments to Quality Systems. If you're up for the challenge, apply today!

Responsibilities of this Role:

• Contribute to the writing, coordination, review and maintenance of the JuMP Risk Management Standard Operating Procedures (SOPs) and associated documents
• Ensure product risk management documentation/files are maintained, with good documentation practices and in compliances with Juno Quality System
• Facilitate planning, execution and completion of risk assessments by providing guidance to cross-functional team members
• Conduct risk reviews and escalate findings, as appropriate, to QRM team
• Track the status of risk mitigation actions through to completion
• Track the implementation of corrective actions associated with risk assessments and verify the actions are align with source event
• Responsible for maintaining the JuMP Quality Risk Catalog/Registry
• Support the creating, revision and review of Quality Risk Management Reports
• Proactively deploy methods and techniques ( e.g. Six Sigma/Lean, FMEA, Root Cause Analysis, etc.) to improve effectiveness of the Risk Management program.
• Collaborate to improve Quality Risk Methodologies and practices
• Generates the data for Quality Risk Management Performance Metrics

Knowledge and Skills Required:
Basic Qualifications:

9+ years industry experience.
GMP experience
BS Degree in Life Science

• Experience with Quality Risk Assessment facilitations and reports
• Experience with performing risk assessments using a variety of tools (e.g. FMEA, PrHA, etc).
• Project Management skills.
• Strong computer skills with MS Office (e.g. Word, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System).

Preferred Qualifications:

• Familiar with biologic and small molecule drug development
• Promotes an environment of accountability, diversity and speaking up
• Experience with risk management in a GCP/GLP/GMP environment
• Ability to analyze, balance, and prioritize risk
• Innovative, proactive, and resourceful; committed to quality and continuous improvement
• Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables

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.