The Quality Engineering and Validation (QEV) team at Juno is responsible for supporting the Quality Management System on review and approval of validation and engineering documents, test protocols, CAPAs, deviations, change controls and any site based technical documentation where Quality Assurance needs to approve before implementation and upon completion at the Juno Manufacturing Plant (JuMP) located in Bothell, WA. The Quality Engineering Sr. Manager is responsible for leading the Team, establishing processes and procedures and providing guidance inside the QEV department and to other departments as to the above activities. This position reports to the Director/Senior Director, Quality Assurance.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Bachelors degree in an engineering discipline
- Master's degree preferred
- Minimum of 7 years working in a Quality, Engineering, Manufacturing role (or combination thereof) within a commercial biopharmaceutical, cellular therapy, or gene therapy organization.
- 5+ years of direct management experience.
Knowledge, Skills, and Abilities
- Strong leader that has developed high performing, independent and capable Teams.
- Knowledge of cGMP regulations, automation standards, FDA, EMA and PMDA guidelines applicable to biologics and cell therapy
- Familiar with automation requirements/guidance (GAMP 5, ISA Standards, etc.).
- Detail oriented, with strong GMP, Quality and Engineering experience.
- Direct experience with providing Quality Engineering guidance and support in a commercial biopharmaceutical, cellular therapy, or gene therapy organization strongly preferred.
- Experience in developing/optimizing Quality Systems related to validation, calibration, maintenance, change control, and automation strongly preferred.
- Excellent communication, trouble shooting, and problem-solving skills.
DUTIES AND RESPONSIBILITIES:
- Review and approve complex documentation in support of GMP operations at JuMP, including but not limited to facility plans, validation and other technical protocols and reports, standard operating procedures, CAPAs, deviations, etc.
- Lead and champion proactive identification and resolution of technical and compliance issues/gaps.
- Provide support to multiple areas within and, potentially, between facilities, requiring a high level of regulatory, Quality System, facility, equipment and process knowledge.
- Ensure adherence to internal procedures and industry/regulatory expectations related to facility/equipment controls and release before, during and after production operations (i.e. routine operations – calibration/maintenance, shutdowns, construction projects, etc.).
- Collaborate with stakeholders within and outside of the JuMP Manufacturing Facility, and communicate equipment, facility and system status.
- Contribute to the development and execution of Juno’s PAI and commercialization readiness plan at JuMP.
- Ensure QEV Team can act as Quality Engineering Subject Matter Experts during regulatory inspections.
- Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of implemented GMP policies and quality management systems.
- Ensure that the QEV Team has meaningful 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.
- Lead and mentor other Quality and Site personnel and enable their individual growth with respect to Quality Systems related to engineering and validation activities at JuMP.
WORKING CONDITIONS (US Only):
- While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings.
- Must be able to obtain gowning qualification to enter a cleanroom environment.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.