The QA Manager will be accountable for the oversight of Quality Assurance Operations within CTCEF Manufacturing . This function safeguards compliance to current 21CFR/FDA regulations, FACT/ Immune Effector Cells regulations, current Good Manufacturing Practices (GMP), MSK and CTCEF Standard Operating Procedures (SOPs). The QA Manager is responsible for managing and supporting all aspects of Quality Assurance and the QA personnel within the multi-user Cell Therapy and Cell Engineering Facility (CTCEF) of MSK while also ensuring integrity of CTCEF products.
Supervise and manage the activities of the CTCEF Quality Assurance team while also hiring, training, and mentoring.
Maintain compliance with federal, state, local, and organizational laws, regulations, guidelines, guidance, and policies.
Develop, implement, and manage all quality assurance processes related to CTCEF and the manufacture of investigational products.
Provide procedural interpretation and assure the training, and qualification of CTCEF and non-CTCEF personnel.
Participate in the identification and setting of appropriate quality standards, specifications, and parameters.
Ensure the Cell Therapy and Cell Engineering Facility meets required quality standards and parameters.
Ensure investigational products manufactured within the multi-user CTCEF meet required specifications.
Oversee CAPA processes to facilitate the identification, analysis, and resolution of issues, defects, and non-conformances.
Ensure timely approval and release of investigational products.
Partner with the Director, Product Development, Production and Research and Technology Mgmt to support and facilitate new product introductions and 3 rd party product transfers.
Assure inspection readiness.
Facilitate internal audits, 3 rd party audits and regulatory agency inspections.
Contribute to the preparation of regulatory documents, research papers, white papers, and other publications.
Oversee the daily workflow and schedule of the QA department.
Conduct performance evaluations that are timely and constructive.
Handle discipline and termination of employees in accordance with MSK policy.
Masters Degree with 7-10 years of related experience in cGMP operations, laboratory management or work in controlled therapeutic manufacturing environments is highly preferred.
Applicants must be familiar with the principles of quality assurance and FDA regulations.
Excellent communication, interpersonal, and organizational skills.
Demonstrated team leader, strong supervisory and leadership skills.
Project management experience.
Equipment qualification and validation experience.
Writing and computer software skills.
Six Sigma Green Belt or Black Belt certification.
May be required to fulfill responsibilities outside of core business hours and days.
At Memorial Sloan Kettering (MSK), we’re not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we’re driving excellence and improving outcomes. For the 28th year, MSK has been named a top hospital for cancer by U.S. News & World Report. We are proud to be on Becker’s Healthcare list as one of the 150 Great Places to Work in Healthcare in 2018, as well as one of Glassdoor’s Employees’ Choice Best Place to Work for 2018. We’re treating cancer, one patient at a time. Join us and make a difference every day.