Senior Quality & Regulatory Specialist

Req ID #:  218973

Northridge, CA, US, 91325

For over 40 years, Charles River Cell Solutions has worked to making a positive impact on the world by providing the highest quality cellular material and services to biotech and pharmaceutical companies and research organizations that are performing innovative research and developing novel cell-based therapies.

We recognize that our success depends on the vision and passion of our employees; that is why we are devoted to making Cell Solutions a rewarding and valuable place to work. We believe in making a difference, and at Cell Solutions, you will make a difference every day.

Job Summary


This position will provide support to ensure the organization maintains compliance with the organization’s Quality Systems, current Good Manufacturing Practices (cGMPs), current Good Tissue Practice (cGTPs), and in adherence with all applicable Federal, State, local, international, and industry regulations and standards.  This position will also oversee the management of regulatory documentation related to the organization’s Institutional Review Board (IRB) activities, will be responsible for maintaining regulatory documentation associated with clinical trials and will assist with the new and ongoing qualification of suppliers performing collections under separate IRB jurisdiction.  The position works closely with QA management staff, the Medical Director, Operations Team, and study sponsors and monitors, to ensure all regulatory documents and requirements are met and up-to-date.  Will support the administration of ongoing research activities and support adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) requirements.

Essential Responsibilities


•    Performs job functions in compliance with all quality systems, FDA/EMA and other applicable international requirements related to GMPs and GTPs, State regulations and AABB Accreditation standards. Maintains training competency on applicable Quality Assurance, Quality Systems, and Regulatory policies and procedures. 
•    Maintains all forms, logs and other applicable records and spreadsheets related to the job functions.
•    Participates in defining and revising policies and procedures related to the position
•    Maintains confidentiality of donor information and materials.
•    Assists in the preparation of records prior to and during external assessments.
•    Maintains confidentiality of proprietary materials and information.
•    Assists other QA staff with regulatory and quality functions as deemed necessary


Job Qualifications


•    B.S., B.A. or Associate Degree preferred, but not required if work history is equivalent.
•    Minimum four (4) years of related experience or equivalent combination of education and experience.
•    Nationally recognized Research Professional Certification (e.g., SOCRA, CRS or Association for Clinical Research Professional) preferred, but not required

The pay range for this position is $74,900 - $82,800. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.


About Charles River Cell Solutions

Charles River Cell Solutions is a global leader and trusted brand in the customization of human-derived biological products and services for biomedical research, drug discovery, and cell and gene therapy development. Cell Solution’s vertically integrated solutions support preclinical research, clinical studies from phases 1 to 3, and commercialization with high-quality RUO and GMP-compliant starting material and apheresis collections. 
In January 2020, HemaCare was acquired by Charles River Laboratories, an early-stage contract research organization (CRO). Combined with Charles River’s integrated, early-stage portfolio of discovery, safety assessment, and manufacturing support services, the acquisition creates a unique, comprehensive solution for researchers and cell therapy developers and manufacturers worldwide to help accelerate their critical programs from basic research and proof-of-concept to regulatory approval and commercialization. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs and enhances their productivity and effectiveness to increase speed to market. We work closely with our clients throughout the clinical process to maximize success and drive positive clinical outcomes. 

Together, with over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical and biotechnology companies, government agencies, and hospitals and academic institutions around the world. 

At Cell Solutions, we are passionate about our role in improving the quality of people’s lives. We have proudly supported the development of 100% of the current commercially available FDA-approved immunocellular therapies. Our mission is to provide a best-in-class portfolio of high quality, customizable human cellular material and services to support drug discovery, scientific research, and cell therapy. This resonates from our employees and impacts our customers because we know that every day is an opportunity to advance discoveries and make a difference in someone’s life. 

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [email protected]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

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