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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

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).

• Provide guidance and mentor direct reports to grow the QA/RA department.

• Review SOPs and policies to ensure compliance with applicable regulatory requirements 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/procedures; Document Control, Deviations, Change Control, CAPA, Internal/customer Auditing, lot release & Quality Management Review.

• Review and provide guidance to validation/revalidation reports (IQ, OQ, PQ).

• Responsible for monitoring the training program for the site.

• Verify all activities related to human subject research are conducted in accordance with IRB determinations and approvals. Ensure data for the quarterly management review is generated for all departments and distributed to all attendees prior to the meeting.

• Conduct internal and external audits and report results to executive management.

• Coordinate and manage Supplier Qualification processes and communicate outcome to Management.

• Lead Process Improvement activities within the QA/RA department or across other departments to streamline and improve existing processes to eliminate non-value added activities.

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

• Communicate all quality related issues and trends to executive management and provide periodic reports on regulatory and quality assurance matters.

• Support regulatory inspections and draft/coordinate responses (if required) to ensure the site is compliant with regulatory requirements.

• Maintain the approved supplier list and ensure all materials received and services performed are from approved suppliers and conform to specifications.

• Ensure all required licenses, permits, registrations and accreditations are up to date.

• Monitor all applicable government and accreditation agency regulations and requirements to ensure compliance and notify applicable department(s) of regulatory changes.

• 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.

• Perform risk analysis to evaluate risks based on scientific data, experience, or documentation to ensure limited risk to the product and patient.

Job Qualifications

• 10+ years of relevant GxP experience either in biotech/pharmaceutical industry, Cell and Gene Therapy with at least 5+ years in Quality Leadership including management of direct reports.

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

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

• 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.

• 5+ years of hosting or leading 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.

• Ability to work effectively with cross-functional teams.

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

• Demonstrated ability in setting successful quality strategies and building and leading the function

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

• Demonstrate excellence in all communication and interpersonal skills. Able to develop and maintain cooperative working relationships with other staff members, management, physicians, and customers.

• Ability to travel 15% domestically and/or internationally.

Compensation Data

The pay range for this position is $169,700 - $209,600. 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 Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.

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.

We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

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.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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.

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