Share Requisition # HRC0368775AWith 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: https://www.cedars-sinai.org/research/areas/biomanufacturing/about.htmlAre 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, additional 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#jobsEducational Requirements:* Bachelor degree in molecular biology, biochemistry or related science/engineering/quality fieldExperience:* One (1) year experience in leading a team/department, required* Five (5) years experience in Quality or Regulatory compliance, required* Seven (7) years experience in Quality or Regulatory compliance, preferred* Working Title: Quality Assurance Lead – Biomanufacturing Center* Department: CS Biomanufacturing Facility* Business Entity: Academic / Research* City: Los Angeles* Job Category: Compliance/Quality* Job Specialty: Quality Measurement & Reporting* Position Type: Full-time* Shift Length: 8 hour shift* Shift Type: Full-timeCedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu). For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through March each year) as a condition of employment, and annually thereafter as a condition of continued employment.