Quality Assurance Manager - Biomanufacturing Center
Cedars-Sinai Medical Center
Location: Los Angeles, California
Internal Number: HRC1031849
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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 Home - CSBIO (csbiomfg.com).
Are you ready to be a part of groundbreaking research?
The Quality Assurance (QA) Manager provides quality assurance oversight of clinical manufacturing of final cell products and identifies and assesses quality risk in activities and processes per regulatory guidelines and standard operating procedures. 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 the CBC. Provides validation support for all equipment and processes; and approves all outcomes, which are essential to the production of biological products. Oversees the documentation of processes and maintenance of records. Leads the construction of a validation master plan for the CBC during the construction phase. All aspects of systematic monitoring and evaluation of the various activities being performed in the cGMP cell manufacturing to ensure that appropriate standards of quality are attained and to assure that products are required quality for their intended use.
Primary Job Duties and Responsibilities:
Develops annual master validation plan and ensures validations are conducted per FDA guidelines, including cleaning validations, process validations, facility and equipment qualifications, and analytical test method validations.
Responsible for compiling, organizing, and storing all session documentation and communicating results as appropriate. Oversees the document control function, including but not limited to issuing records, maintaining electronic and hard copies of master records, and maintaining hard copies of historical records.
Manages the regulatory inspections and auditing, comparing actual conditions to requirements and reporting to management; provides confidence that quality requirements are fulfilled.
Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories
Oversees and conducts cGMP and ISO training to comply with regulatory requirements
Maintains and improves quality systems per FDA cGMP parts 210 and 211
Oversees CAPA, deviations, NCMR, and product complaint systems and ensure discrepancies are properly documented, investigated and completed in a timely manner
Oversees work of direct reports; distributes workload, and cross-train staff on different quality areas. Assists in interviewing, hiring, developing, and managing employees.
Designs and schedules training programs, as well as refresher courses. Responsible for managing quality standards on the production lines through adequate training.
Provides expertise in translating quality assurance standards and participates as a team member on quality/regulatory issues.
Provides leadership, coaching and mentoring to assure a competent, efficient and effective QA organization that works well in cross-functional teams. Assures staff is current with all required training. Provides QA leadership, direction and support of corrective action / preventive actions resulting from internal and external audits and other focused quality initiatives. Supports the development and ongoing generation of quality metrics.
Performs all other duties as assigned.
Bachelor's degree in quality assurance, biological sciences or life sciences is required. Master's degree is preferred.
Licenses and Certifications:
Quality Auditor (CQA), Pharmaceutical GMP Professional (CPGP), is preferred.
Experience and Skills:
Three (3) years of experience working in a regulated industry, biologics, or biotech is required.
Collaborates to problem solve and make decisions to achieve desired outcomes.
Establishes effective working relationships with cross-functional team(s).
Responds timely, effectively and appropriately to deliverables.
Shares knowledge, time and expertise to assist other members of the team.
Cultivates and maintains strong customer relationships and rapport with stakeholders and/or client groups.
Ensures practices and procedures are inclusive of interpersonal and cultural diversity.
Identifies and responds appropriately to both internal and external customer needs utilizing available resources.
Represents the company with external constituents.
Responsible for hiring, onboarding, managing schedules, personnel actions, performance reviews, and performance improvement plans.
Plans, leads, and directs work of staff to ensure goals and objectives are completed within established budget and deadlines are met.
Supervises the day-to-day work of employees, assigns work, and ensures tasks are completed and deadlines are met.
Acts as a team lead to include overseeing the work of others, assigning or allocating work to team, and ensuring tasks are completed according to deadlines and quality standards.
Working Title:Quality Assurance Manager - Biomanufacturing Center Department:CS Biomanufacturing Facility Business Entity:Academic / Research Job Category:,Academic/Research,Academic/Research Job Specialty:Research Studies/Clinical Trials Position Type:Full-time Shift Length:8 hour shift Shift Type:Day
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 opport...unities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major teaching 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.