Quality Assurance Lead - Biomanufacturing Center

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.org)

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.

As a QA Lead, primary duties and responsibilities include:

• 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