Quality Assurance Manager - Biomanufacturing Center
Posted on: September 24, 2022
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 Home - CSBIO ().
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
- Maintains and improves quality systems per FDA cGMP parts 210
- 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
- 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),
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
- Establishes effective working relationships with
- Responds timely, effectively and appropriately to
- Shares knowledge, time and expertise to assist other members of
- 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, leads, and directs work of staff to ensure goals and
objectives are completed within established budget and deadlines
- 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
Department:CS Biomanufacturing Facility
Business Entity:Academic / Research
Job Specialty:Research Studies/Clinical Trials
Shift Length:8 hour shift
Keywords: CEDARS-SINAI, Alhambra , Quality Assurance Manager - Biomanufacturing Center, Executive , Alhambra, California
Didn't find what you're looking for? Search again!