Director of Quality Assurance - Cell and Gene Therapy Operations

About City of Hope

City of Hope is an independent biomedical research and treatment organization for cancer, diabetes, and other life-threatening diseases.

Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope's translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and numerous breakthrough cancer drugs are based on technology developed at the institution. AccessHope, a subsidiary launched in 2019 serves employers and their health care partners by providing access to City of Hope's specialized cancer expertise.

A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation's "Best Hospitals" in cancer by U.S. News & World Report and received Magnet Recognition from the American Nurses Credentialing Center. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona.

City of Hope's commitment to Diversity, Equity, and Inclusion

We believe diversity, equity and inclusion is key in serving our mission to provide compassionate patient care, drive innovative discovery, and advance vital education focused on eliminating cancer and diabetes in all our communities. Our commitment to Diversity, Equity and Inclusion ensures we bring the full range of skills, perspectives, cultural backgrounds, and experiences to our work -- and that our teams align with the people we serve to build trust and understanding. We are dedicated to fostering a community that embraces diversity - in ideas, backgrounds, and perspectives; this is reflected in our work and represented in our people.

Position Summary

We are looking for a leader to head the Quality Assurance (QA) in Cell and Gene Therapy Operations (CGTO) at City of Hope (COH). This role reports to the Vice President of Cell and Gene Therapy Operations (CGTO).

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. The successful candidate will oversee a Quality Assurance team of more than 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.

The Director of QA will be part of the GMP leadership team, that is focused on transformative change and fostering a work culture consistent with City of Hope values (including a sense of urgency, intellectual curiosity, excellence, and collaboration). The successful candidate will be passionate about overseeing Quality Assurance and advancing to the clinic a broad variety of Phase I/II therapeutics.

Essential Functions:

* 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.

* Ensure compliance of cGMP facility operations in accordance with:

o FDA drug manufacturing licensure and registration requirements for GMP facilities

o ISO cleanroom operating standards

o ICH guidance documents.

* 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.

* Direct the conduct of vendor qualification and auditing activities.

* 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.

* Serve as a member on various institutional compliance oversight committees and provide input to resolve potential compliance concerns.

* Work with Project Management team to develop budget related to QA support of contract manufacturing projects.

* Liaise with key stakeholders, including but not limited manufacturing, quality control, regulatory affairs personnel, internal investigators, and external collaborators.

* Recruit, train, and mentor staff responsible for quality operations at COH.

Basic education, experience and skills required for consideration:

* 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.

* 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

Additional Information:

As a condition of employment, City of Hope requires staff to comply with all state and federal vaccination mandates.

The estimated pay scale represents the typical [salary/hourly] range City of Hope reasonably expects to pay for this position, with offers determined based on several factors which may include, but not be limited to, the candidate's experience, expertise, skills, education, job scope, training, internal equity, geography/market, etc. This pay scale is subject to change from time to time.

City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.