Juno Therapeutics Bothell , WA 98021
Juno is seeking a Sr. Associate Quality Investigator at the Juno Manufacturing Plant (JuMP). This role is responsible for leading deviation investigations to ensure the written investigation report contains the technical merit and completeness according to regulatory expectations. This position will be responsible for operating cross-functionally, collecting necessary data and information associated with the manufacturing and laboratory deviations. This position will lead root cause analysis sessions with site SME's and determine the associated corrective action to prevent the deviation from recurring. This person will be a key player in the JuMP Quality Assurance team and a champion for quality priority principles and compliance within the JuMP organization. This position reports directly to the Quality Manager responsible for deviation investigation management.
Responsible for the Quality Assurance GMP deviation investigation lead at JuMP, and ensuring adherence to applicable GMP regulations and Juno policies and procedures
Provide consistent direction and ensure timely completion of deviation investigations to ensure on-going consistency for investigation reports that will stand alone during regulatory inspections.
Develop a comprehensive understanding of the manufacturing processes followed for JUNO products and the associated risk management control strategy developed to identify process risks and associated critical controls around the associate processing steps.
Develop the necessary skills using the appropriate tool(s) and statistical application in risk management and Root Cause Analysis to enable the effective and timely close of deviation investigations.
Provide consistent oversight and recommendation of quality product disposition according to the results of the investigation.
Collaborate with stakeholders and management, and communicate investigation status to management as appropriate.
Participate in Material Review Board meetings and evaluate recommendations made by the board regarding product disposition as it relates to the appropriate investigation.
Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of implemented GMP policies and quality management systems.
Contribute to the development and execution of Juno's PLI and commercialization readiness plan at JuMP
Develop individual goals and ensure the timely completion of all deliverables.
Champion and foster a positive and successful collaborative quality culture, aligned with Juno's existing culture.
Mentor other Quality personnel and enable their individual growth with respect to deviation investigation completeness and GMP expectations.
Act as subject matter expert for QA oversight of GMP deviation investigations during regulatory inspections.
Qualifications and Education Requirements
BS/MS in relevant Science or Engineering discipline and 5+ years of experience in execution of deviation investigations.
Experience in Quality Assurance function or technical MSAT role in a GMP manufacturing operation.
Expertise in GMP compliance and FDA/EMA regulations.
Background in Protein Biologics or Cell Therapy Manufacturing is required
Demonstrated excellence in written and verbal communication
Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
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