Charles River Laboratories Visa Sponsorship USA

INTRODUCTION

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

JOB SUMMARY

The Associate Director Quality is responsible for ensuring that Quality performance, compliance, and operational excellence are embedded and maintained across all strategic initiatives, GMP operations, and support functions at the Rockville site. This role provides leadership for Quality Operations Oversight, On-the-Floor Quality, and client-facing Quality programs supporting the CDMO-Rockville portfolio. The Associate Director leads, develops, and mentors Quality staff while providing strategic direction to maintain compliance with regulatory requirements in support of existing and new cell-based gene therapy manufacturing.

KEY RESPONSIBILITIES

Quality Leadership & Strategic Oversight

• Serve as a strong, accountable leader who motivates, mentors, and develops the Quality team; sets clear expectations and drives ownership, performance, and continuous improvement.
• Apply deep process knowledge and technical acumen—gene therapy preferred, biologics acceptable—to drive effective decision-making, even in areas with limited historical precedent.
• Represent Quality as an FDA-facing subject matter expert and provide expertise to support preparation for regulatory inspections and client audits.
• Promote a risk-based, phase-appropriate, and agile quality culture; demonstrate balanced judgment across Quality, operational timelines, and client needs.

Operational Quality Oversight

• Ensure Quality deliverables for batch record review, lot disposition, and product release meet internal and external expectations and are executed in a timely, compliant, and client-focused manner.
• Oversee the review and approval of GMP records including batch production records, QC test reports, EM data, cleaning records, equipment and facility records, assay qualifications, stability protocols, and related documentation.
• Manage execution of on-the-floor Quality operations, including walkthroughs of manufacturing, QC labs, storage, and material receiving areas to ensure GMP compliance.
• Provide technical expertise during investigations; support data gathering, root-cause analysis, and development of corrective and preventive actions (CAPA).

Client & Project Support

• Monitor Quality support activities for client programs and ensure issues are escalated appropriately to maintain on-time project delivery.
• Partner with Manufacturing, Technical Operations, and cross-functional stakeholders to resolve issues, identify root causes, and implement effective CAPA.
• Act as a role model for effective problem-solving and triage by demonstrating sound judgment, balanced risk assessment, and strong communication.

Quality Systems & Documentation

• Oversee the revision, issuance, and tracking of controlled documents supporting bulk and sterile fill operations.
• Perform and/or approve Quality Control data review, audit trail review, and other compliance checks.
• Support cross-training and participate in other Quality functions including Quality Systems, Training, Document Control, and Supplier Quality.
• Contribute to internal and vendor audits; identify deficiencies and ensure timely closure of observations.
• Drive continuous improvement initiatives that support self-detecting, self-correcting systems and operational excellence.

Leadership, Communication & Issue Resolution

• Notify senior management of critical issues with potential impact to manufacturing timelines, offering feasible solutions and risk-mitigation strategies.
• Actively participate in hiring, onboarding, and developing new team members.
• Ensure effective communication at all levels of the organization and with external clients.

JOB QUALIFICATIONS

• BS/BA required; MS in a scientific or technical discipline preferred.
• Minimum 8 years of Quality leadership experience in biologics, pharmaceuticals, or cell/gene therapy.
• Experience with CDMO operations and/or gene-modified or cell-based therapies required.
• Demonstrated experience reviewing QC test results and GMP batch records for clinical and commercial manufacturing.
• Strong working knowledge of FDA, EMA, ICH regulations and industry best practices.
• Experience with TrackWise or similar electronic Quality management systems preferred.
• Excellent interpersonal, negotiation, and conflict-resolution skills; able to influence across levels and functions.
• Exceptional written and verbal communication skills.
• Strong organizational capability to manage complex processes and competing priorities.
• Proven ability to lead investigations, risk assessments, and CAPA programs.
• Internal or external auditor experience.
• Hands-on, detail-oriented, proactive, and able to make informed decisions in ambiguous situations.

COMPENSATION DATA

The pay rate for this role is $156,000 - $176,000 per year. 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’S CDMO SERVICES

With over 20 years of experience and industry-leading expertise, Charles River’s cell and gene therapy Contract Development and Manufacturing Organization (CDMO) group supports biotechnology and pharmaceutical companies in advancing their complex programs from early development through commercialization. Our integrated, phase-appropriate CDMO capabilities—including plasmid DNA, viral vector, and cell therapy manufacturing—enable seamless development and faster timelines. With centers of excellence in the US and UK, we offer GMP-compliant and research-grade solutions, along with comprehensive analytical services and regulatory support. Whether clients need end-to-end development, standalone services, or insourced support, our CDMO team provides custom solutions to meet evolving program needs. From process development in Hanover to viral vector manufacturing in Rockville, large-scale cell therapy production in Memphis, and plasmid DNA services in Keele, we simplify the supply chain and accelerate cell and gene therapy breakthroughs.

ABOUT CHARLES RIVER

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

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 companies, 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.

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 is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

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.