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Director, Quality Assurance & Regulatory Affairs

Charles River Laboratories International Inc (CRL)

Northridge, CA, US, 91325

Director, Quality Assurance & Regulatory Affairs Req ID #:  188794 Location: 

Northridge, CA, US, 91325 For over 40 years, HemaCare, a Charles River company, 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 HemaCare a rewarding and valuable place to work. We believe in making a difference, and at HemaCare, 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 Director, Regulatory Affairs and Quality Assurance is responsible for ensuring the business 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, Federal, International, FDA, AABB, OSHA and other applicable agencies).  Monitoring is achieved through performing internal audits, managing deviations, BPDR, MRB, review, and approval of standard operational procedures (SOP) and other Quality Systems reports.

•    Maintain and approve written procedures for production and process control designed to assure that products have the safety, quality, identity, purity, and strength that they purport to possess.

•    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.

•    Facilitate the development and maintenance of quality systems supporting pre-clinical, clinical, manufacturing, storage, and distribution activities related to GMP products.

•    Maintain a Master Validation Plan and system that describes initial qualification (IQ, OQ, PQ) and revalidation.

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

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

•    Evaluate and approve employee training and competency programs to ensure compliance with all regulatory requirements.

•    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.

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

•    Develop and maintain a risk management/analysis system, according to ICH guidelines to evaluate risks based on scientific data, experience, or documentation to ensure limited risk to the product and patient.

•    Oversight of document control activities including working with document control staff to maintain strict document control of SOPs, forms, validation plans and other associated documents.

•    Expeditiously expand, build, and train the QA & RA team to meet all applicable regulatory compliance regulations and fulfill oversight responsibilities for Local, State, Federal, International (including, but not limited to, European Medicines Agency (EMA), FDA, AABB, OSHA and other app licable agencies. Job Qualifications  

•    BA/BS degree in life sciences.  Advance degree is highly preferred. 

•    10+ years of relevant GxP experience in Cell and Gene Therapy with at least 7+ years in Quality Leadership.

•    5+ years management experience leading matrix, global teams required.

•    Process improvement/Lean Six Sigma/Agile methodology experience preferred.

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

•    Substantial experience in leading and participating in regulatory inspections and preparing staff for regulatory inspections.

•    Strong working knowledge of global GMP/GLP requirements, regulations, and guidance; sound judgment and commitment to ethical conduct.

•    Experience in IT and software validation.

•    Experience with FDA and EMA requirements related to cleanrooms and sterile manufacturing required.

•    Expert knowledge of quality risk assessment and management methodologies, including successful application and risk remediation.

•    Proven track record in establishing a quality organization and managing GxP Quality staff.

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

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. 

Vaccine Mandate

Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19.  Our main priority is the wellbeing, health, and safety of our people. We require proof of vaccination from all employees. 

Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

 

About HemaCare 

HemaCare, a Charles River company, 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. HemaCare’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 HemaCare, 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

Job Segment: Quality Assurance, Pharmaceutical, Document Control, Lean Six Sigma, Six Sigma, Technology, Science, Administrative, Management

Job posted: 2022-08-11

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