Director of Quality Assurance - Cell and Gene Therapy Operations

City of Hope•Duarte, CA

59d

About The Position

Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research. We are looking for a leader to head the Quality Assurance (QA) in Cell and Gene Therapy Operations. This role reports to the Vice President of Cell and Gene Therapy Operations in the Center for Bioinnovation and Manufacturing. COH has a mission to transform the future of cancer care. In support of this mission, COH has over 20+ years of experience in GMP production of Cell and Gene Therapies holding >120 active INDs and supported by a 100+ person GMP team. You will oversee a Quality Assurance team of 15- 20 people that supports projects for both internal COH investigators and external biotech collaborators. Autologous and allogeneic projects consist of immunotherapies (e.g. CAR-T, CAR-NK, TILs) and stem cells (e.g. iPSCs, MSCs, NSCs), as well as viral vector productions (e.g. Lentivirus, etc) and small molecule manufacturing. As a successful candidate you will: Oversee GMP and GLP quality assurance operations at COH. Initiate, implement, and enforce quality policies and procedures impacting institutional compliance with federal and state regulations. Oversee Quality Management Systems, including deviations and investigations, corrective and preventive actions, document control, change control, GxP training, compliance of activities within cGMP facilities, and ensure continuous improvement of quality systems. Drive the continuous improvement of Quality systems, by establishing more efficient/effective processes and incorporating forward-looking technologies (e.g. electronic QMS, eBRs, AI-based approaches, etc) Host regulatory health authority and client audits and submit written responses to findings in a timely manner; Assess audit findings and implement quality systems improvements as needed. Help oversee materials management, release of raw materials, drug substance, drug product and determination of final product disposition. Develop quality/KPI metrics to support GMP activities and quality management review. In collaboration with manufacturing teams, develop raw material standards to ensure suitability for use in GMP manufacturing. Work with Project Management team to develop budget related to QA support of contract manufacturing projects. Recruit, train, and mentor staff responsible for quality operations at COH.

Requirements

Bachelor's degree in scientific or engineering discipline. MS or PhD in scientific or engineering discipline preferred.
10+ years of experience in QA in a pharmaceutical or biotech environment with at least 5 years in a leadership role.
Working knowledge of quality systems requirements.
Extensive knowledge of US federal regulations 21 CFR 210, 211, 312, 600, 610 as pertains to cGMP, GLP, ISO and other regulatory guidelines pertinent to manufacturing and release of products under cGMP. Grasp of EMA and Health Canada regulations.
Experience with FDA facility licensure.
Extensive experience with leading internal and external audit activities.

Nice To Haves

Quality management certification from an accredited program is preferred
Knowledgeable and experienced with oversight of cell and gene therapy production, testing and quality oversight is preferred

Responsibilities

Oversee GMP and GLP quality assurance operations at COH.
Initiate, implement, and enforce quality policies and procedures impacting institutional compliance with federal and state regulations.
Oversee Quality Management Systems, including deviations and investigations, corrective and preventive actions, document control, change control, GxP training, compliance of activities within cGMP facilities, and ensure continuous improvement of quality systems.
Drive the continuous improvement of Quality systems, by establishing more efficient/effective processes and incorporating forward-looking technologies (e.g. electronic QMS, eBRs, AI-based approaches, etc)
Host regulatory health authority and client audits and submit written responses to findings in a timely manner; Assess audit findings and implement quality systems improvements as needed.
Help oversee materials management, release of raw materials, drug substance, drug product and determination of final product disposition.
Develop quality/KPI metrics to support GMP activities and quality management review.
In collaboration with manufacturing teams, develop raw material standards to ensure suitability for use in GMP manufacturing.
Work with Project Management team to develop budget related to QA support of contract manufacturing projects.
Recruit, train, and mentor staff responsible for quality operations at COH.