With your help, we can change the future of healthcare!
The Cedars-Sinai Biomanufacturing Center (CBC) is a state-of-the art facility that comprises of a cGMP cell manufacturing facility housing multiple cleanroom cell production suites and process development rooms for producing the next generation of cell and gene therapies. With world class expertise in stem cell (iPSC) biology, bioprocessing, translational, regulatory and manufacturing, Cedars-Sinai is committed to pushing the frontiers of medicine and discovering new technologies and innovations that will impact how we diagnose and treat disease. To learn more about the CBC, please visit: GMP Biomanufacturing Services | Cedars-Sinai (cedars-sinai.edu)
Are you ready to be a part of groundbreaking research?
As a Quality Assurance (QA) Lead, conduct complex work under minimal supervision and with wide latitude for independent judgment and oversee a team to implement inspection plans, quality plans, support auditing functions, and/or evaluate supplier performance. Be a contributor to the planning, implementation, and administration of cost effective Quality Programs, ensuring that a system is in place which will meet contractual quality requirements. The QA Lead will be responsible for overseeing quality assurance of clinical manufacturing for quality standards of final cell products and identifies and assesses quality risk in activities and processes per regulatory guidelines, cGMPs, and standard operating procedures (SOP). In addition, being responsible for ensuring compliance with all Federal and State laws and regulations and other accrediting agency requirements in the collection, processing, preparation, and distribution of biopharmaceutical products manufactured in cGMP facilities of the CBC. All aspects of systematic monitoring and evaluation of the various activities being performed in the cGMP cell manufacturing that appropriate standards of quality are attained and to ensure that products are required quality for their intended use.
Primary Duties and Responsibilities:
Assisting in the third-level enforcement of quality processes in compliance with quality procedures; the overall objective is to support external sharing of documents and detailed discussions of CBC quality management system.
Developing and maintaining cGMP documents and ensure compliance with company procedure and applicable regulatory requirements.
Performing investigations, identifying gaps in the process, following through corrective and preventive actions.
Managing and scheduling the internal audit program, including training all internal auditors, issuing resulting corrective actions; may perform external cGMP audits.
Serving as SME on the use of risk-based tools for qualification, training, monitoring and disqualification.
Assessing and approving any changes to cGMP-systems to ensure validated state of the systems is maintained.
Maintaining change control system and processes to ensure the compliance with the regulations such as cGMPs, and 21 CFR Part 11.
Establishing, delegating, and monitoring the workflow for a team of department QA staff.
Providing ongoing training, guidance, and work direction to QA Staff.
Bachelor degree in molecular biology, biochemistry or related science/engineering/quality field, required.
Licenses and Certifications:
Quality Auditor, CQA from ASQ or equivalent is preferred.
Experience and Skillset:
One (1) year experience in leading a team/department, required.
Five (5) years experience in Quality or Regulatory compliance, required. Seven (7) years experience, preferred.
Working Title: Quality Assurance Lead - Biomanufacturing
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major t...eaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.