Associate Director, Quality Assurance & Regulatory Affairs

Associate Director, Quality Assurance & Regulatory Affairs Req ID #:  214487 Location: 

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.

IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly.   Job Summary The Associate Director, QA / RA is responsible for ensuring the company maintains compliance with the following: Quality Systems, cGMP and cGTP models, Institutional Review Board determinations, and all applicable Federal, State, local, international, and industry regulations and standards.  

Essential Responsibilities:

•    Responsible for monitoring compliance with all applicable regulations (local, State, International, FDA, AABB, FACT, OSHA, and other applicable agencies).  Monitoring is achieved though performing internal audits, managing deviation, BPDR, MRB, review and approval of standard operational procedures (SOP) and other Quality Systems reports.

•    Develop, operate, and maintain the effectiveness of the Quality Management System, the processes and procedures; Document Control, Deviations, Change Control, CAPA, Internal Auditing & Quality Management Review.

•    Responsible for the design, implementation, and effectiveness of the cGMP training system.

•    Responsible for all official communications with Federal and State regulatory agencies including timely response to external inspections and assessments.

•    Provide consultation for operations concerning IRB Activities, regulations, standard operation processes, and validation protocols.

•    Verify all activities related to human subject research are conducted in accordance with IRB determinations and approvals.

•    Prepare for initial ISO certification audit and establishment of Registrar. Following initial certification, maintain standards appropriately to ensure continuing accreditation to ISO standards.

•    Coordinate and Manage Supplier Qualification and Vendor Qualification processes. Maintain all applicable documentation and records.

•    Process Improvement activities including developing statistical reports for tracking and trending quality system reports for reporting to executive management.

•    Responsible for developing, maintaining, and training on QA, Quality Systems, and Regulatory policies and procedures.  Includes Document Control and Records Management policies and procedures.

•    Support regulatory inspections and Supplier Qualification Audits, coordinate responses, maintain all applicable documentation and records.

•    Obtain and maintain all required licenses, permits, registrations, and accreditations.

•    Monitor all applicable government and accreditation agency regulations and requirements to ensure compliance.  Notify operations of regulatory changes.

•    Communicate with and advise, as appropriate, client institutions regarding regulatory and quality assurance requirements and activities.

•    Quality system reports oversight, including deviations, complaints, exceptions, MRBs, etc. Monitors compliance and generates statistics for tracking and trending purposes. Assist in the development of Corrective Actions and Preventative Actions.

•    Oversight of donor deferral activities including product quarantine/retrieval/recall, consignee notifications and Federal, State and County notifications, and review of records: Post Donation Information, abnormal test results, potential duplicate donors.

•    Interface with regulatory agencies, accreditation bodies, and customers on issues related to Quality and Regulatory systems and/or IRB issues.

•    Work closely with HemaCare Medical Director to ensure that operational and clinical activities, policies, and procedures meet standards to ensure donor, staff and patient safety. Job Qualifications •    Bachelor’s degree in biological sciences discipline required. Advanced degree is a plus.

•    At least 7 years of progressive quality or manufacturing experience in cell therapy, pharmaceutical, biotech, or biologics operations preferred. 

•    A minimum of 3 years supervisory or management experience required.

•    Clinical Research certification or MT (ASCP) SBB preferred.

•    Strong working knowledge and ability to apply GMPs and GTPs in conformance to FDA, EU, and AABB standards. 

•    Must have a good understanding of regulatory compliance frameworks applicable to blood banking, cellular therapy, and human subject research protection requirements.

•    Thorough understanding of key supporting quality systems including document management, training, change control, deviation, non-conformance, and CAPA. Requires expertise in performing root-cause analysis.

•    Working knowledge of federal and state requirements for human subject research protection, peripheral stem cell collections, and blood donor centers.  

•    Proficient use of Microsoft Office products, including Word, Excel, Outlook, and PowerPoint.

The pay range for this position is $137,900-186,500. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 

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 crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.

Nearest Major Market: Los Angeles

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