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
This role serves as a senior Quality Assurance Subject Matter Expert (SME) supporting the GMP cell therapy manufacturing operations. This roles plays a strategic part in ensuring compliance across the quality system, providing technical leadership for complex investigations, regulatory readiness, and cross-functional quality decisions. This position is hands-on expert who can partner across departments while maintaining a strong compliance posture in a fast-paced evolving environment.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Performs full investigations of major events with potential product quality impact for complex products to identify the root cause, impact assessment, and CAPA to assess quality requirements for compliance with regulatory requirements
• Provides Quality Assurance (QA) assessment and approval for Change Controls, supports Quality Management activities with strategic initiatives and metrics, assembles Change Control Assessments, supports Deviation Risk Assessments and reviews and approves CAPAs
• Lead or contribute significantly to top regulatory inspections preparation, hosting and response efforts. Offer guidance on Good Manufacturing Practices (GMP) compliance strategies related to cell therapy processes, raw materials, and supply chain controls.
• Collaborate cross-functionally with Manufacturing, MSAT, Supply Chain, Quality Control and Regulatory to drive right-first-time execution and continuous improvement.
• Support QA oversight of aseptic operations and cleanroom behavior, serving as a QA lead during critical operations in compliance with cGMP and SOP regulations, as needed.
• Actively lead, coach and mentor other quality professionals and other individuals from all parts of CRL with varying levels of experience to deepen business and quality acumen
• Perform preventative tasks and provide documentation to avoid deviations
• Perform periodic assessments of Quality related data and documentation to maintain a state of audit readiness
• Influences as a resource and departmental SME for Quality related questions or topics including Regulatory, Corporate, and Site-specific requirements
• Delegate tasks within the Quality Operations function and drive progress to completion during execution to the required standard and ensure on-time completion of Quality deliverables
• Ensure strategic alignment with deliverables by leading execution efforts across key internal stakeholders
• Strong attention to detail
• Triage real-time quality impact of events in conjunction with employees in support of deviation management
• Conduct internal audits of facility, equipment, manufacturing areas, and warehouse and provide written reports summarizing findings
• Recommend improvements in QA through procedures or processes as they relate to inspection readiness and compliance
• Perform trending and analysis of deviations and works with responsible area owners to identify opportunities for improvement
• Build trust and influence within different departments of the operation by being a top Quality advisor to Operators
Job Qualifications
- Bachelors degree in a life science or related field preferred
- Minimum of 8 years GMP related experience in biopharmaceutical and/or pharmaceutical or related industry or a combination of 6 years of education and related work experience required
- Understanding of US and EU cGMP guidelines and requirements
- Ability to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc.) to functional area leadership
- Strong analytical and problem-solving skills coupled with the ability to work both independently and in a team environment
- Ability to understand operational documents for GMP compliance, accuracy, and completeness
- Ability to work by influencing a matrix management system and to gain the cooperation of others
- Ability to multi-task effectively
- Excellent written and verbal communication skills
- Ability to prioritize daily activities in order to meet internal needs on time of established time lines in a fast-paced environment
- Proficient in computer system use, including but not limited to Microsoft Office (Word, Excel, Power Point) and Quality Management Systems such as Trackwise, SmartSolve, and Maximo
About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.
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 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, or 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 [email protected]. 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.
Helping you find your moment
You take great care and effort when you apply for a job with us. Rest assured that we’ll be just as diligent in finding the role that’s right for you. Here’s how our hiring process works:
Job Search
Learn about CRL, our culture, and why we do the work we do while also searching for roles that match your interests and expertise.
Application
Create a profile and apply to as many roles as you have an interest.
Note: Depending on the role, you may be required to include a resume in your application.
Assessment and application review
Complete assessments, if requested, to determine whether the role is likely to be a good fit for you – and vice versa. The recruiter will review your resume and qualifications against the requirements of the role and will determine next steps.
Note: At any point in the process, you can log into your profile to review the status of your application.
Interview
Engage in our inclusive interview process by meeting with a diverse group of interviewers who will provide information on the company, culture, and your role while also asking you questions to assess your skills, interests, and expertise. This is also a great time for you to ask questions.
Note: Charles River leverages technical and behavioral-based interview questions based on our DNA (Care, Lead, Own, and Collaborate). Please familiarize yourself with the DNA and be prepared to relate your experiences to them.
Job offer and onboarding
Receive a competitive offer either by phone or email from a Charles River recruiter or hiring manager. The offer will include your title, salary, location, and other relevant information.
Note: Upon acceptance, you will work with your recruiter to confirm a start date and will receive paperwork to electronically complete prior to your start. For US-based roles, upon your acceptance, you will be required to take a pre-employment drug screen and pass a criminal background check.
Job Search
Learn about CRL, our culture, and why we do the work we do while also searching for roles that match your interests and expertise.
Application
Create a profile and apply to as many roles as you have an interest. Note: Depending on the role, you may be required to include a resume in your application.
Assessment and Application Review
Complete assessments, if requested, to determine whether the role is likely to be a good fit for you – and vice versa. The recruiter will review your resume and qualifications against the requirements of the role and will determine next steps.
Note: At any point in the process, you can log into your profile to review the status of your application.
Interview
Engage in our inclusive interview process by meeting with a diverse group of interviewers who will provide information on the company, culture, and your role while also asking you questions to assess your skills, interests, and expertise. This is also a great time for you to ask questions. Note: Charles River leverages technical and behavioral-based interview questions based on our DNA (Care, Lead, Own, and Collaborate). Please familiarize yourself with the DNA and be prepared to relate your experiences to them.
Job offer and onboarding
Receive a competitive offer either by phone or email from a Charles River recruiter or hiring manager. The offer will include your title, salary, location, and other relevant information. Note: Upon acceptance, you will work with your recruiter to confirm a start date and will receive paperwork to electronically complete prior to your start. For US-based roles, upon your acceptance, you will be required to take a pre-employment drug screen and pass a criminal background check.
Featured jobs
Important things are happening every moment at Charles River. This means exciting new career opportunities for you to explore. Take a look and apply today!
Looking for something else? Search all jobs.
Moment by moment
At Charles River, you’ll be able to contribute to incredible breakthroughs while experiencing exciting opportunities for growth and development.
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UX/UI Designer
Advocate for user-centered design solutions. Create distinctive, consistent, branded digital experiences across multiple platforms, devices, and channels.
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Senior UX/UI Designer
Define and drive UX/UI strategies and interaction designs – from scratch and for scale – that solve business and user problems.
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Associate Director
Work with Senior UX/IX Designers and developers to assess problems and develop solutions. Execute on plan by building coding standardizations and automating processes.
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Director, Digital Data Enablement
Lead UX management and operational teams across business units and technical teams. Identify and define fit-for-purpose strategies to integrate best practices.
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Senior Director UX/UI Design
Mentor, coach, and guide designer teams on design strategy related to research insights, execution, continuous integration, and automated deployment.
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Animal Care Technician I - V
Maintain the well-being of our animals by providing food, water, and a clean environment.
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Animal Care Technologist I - V
Provide specialized care to maintain and monitor our animals’ health and physical environment.
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Veterinary Technician
Help monitor, document, and triage all laboratory animal health cases.
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Team Leader / Supervisor
Supervise, train, mobilize, empower, and develop a high-performing team.
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Research Associate
Coordinate and plan activities according to study plan guidelines.
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Intern Level I
Support process/procedure improvement based on site and department needs. Gain knowledge of our corporate environment to navigate cross-functional department collaboration.
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Intern Level II
Complete comprehensive departmental projects incorporating mentorship of Level I interns as a professional development component.
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Biomanufacturing Technician I-III
Oversee the production, formulation, and banking of cellular products while maintaining compliance with GMP, GDP, and aseptic guidelines.
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Biomanufacturing Lead / Specialist
Maintain in-depth knowledge of specialized equipment to address questions as a Subject Matter Expert for the required equipment.
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Clinical Veterinarian I-III
Responsible for delivering professional veterinary services and helping to manage all phases of health care for the animal colony.
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Senior Clinical Veterinarian
Utilize knowledge of laboratory animal medicine to optimize the scientific objectives of animal research protocols.
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Principal Veterinarian / Associate Director
Conduct veterinary consults, make treatment recommendations, communicate with study directors, and follow cases through resolution.
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Director, Laboratory Animal Medicine
Provide technical and professional oversight of all animal care and use functions involving site laboratory animals.
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Technician I-III
Follow SOP and protocols in the areas of animal handling, husbandry, and blood/urine collection.
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Technician IV-V
Handle advanced technician duties, including anesthesia, leadership and specialized sample collections.
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Project Leader (Scientific)
Serve as a scientific expert for the Lab with responsibility for staff-conducted studies.
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Team Leader (People Leader)
Oversee team activities and gain leadership skills on the path to becoming a Team Supervisor.
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Team Supervisor (People Leader)
Responsible for overall employee supervision, staff development, and team success.
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Financial Analyst I
Help analyze financial data, extract/define relevant information, and interpret data.
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Financial Analyst II
Responsible for analysis, forecasting, budgeting, accounting administration, and reporting of projects.
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Senior Financial Analyst
Handle weekly and monthly forecasting and annual budget preparation. Prepare financials and key indicators for business reviews.
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Manager, Business Finance
Partner with operating businesses to raise standards in key decision areas. Present a dynamic industry, competitor, and economic context.
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Finance Director, Operations
Support all business aspects, working with site teams to direct weekly/monthly forecasting and annual budget preparation.
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Biomanufacturing Technician I
Support the production, formulation, and banking of novel cellular products (including cGMP, GDP, and aseptic processing).
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Biomanufacturing Technician II
Perform specialized activities in the production, formulation, and banking of novel cellular products (including cGMP, GDP, and aseptic processing). Train Biomanufacturing Technician 1.
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Biomanufacturing Technician III
Help advance the production, formulation, and banking of novel cellular products (including cGMP, GDP, and aseptic processing) while interacting with clients.
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Biomanufacturing Lead / Specialist
Maintain in-depth knowledge of specialized equipment to address questions as a Subject Matter Expert for the required equipment.
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Biomanufacturing Supervisor
Oversee biomanufacturing personnel, ensuring compliance with cGMP’s, CRL quality systems, and process documents in biomanufacturing.
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Biomanufacturing Manager
Lead biomanufacturing activities in the start-up and cGMP production of novel cellular products. Schedule and manage staff, ensuring a safe and compliant working environment.
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Client Manager
Ensures high-quality customer service through multi-site coordination. Deliver timely, accurate, and comprehensive responses to sponsor requests.
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Business Development Director
Deliver profitable sales growth by targeting and visiting clients to build strong relationships and customer loyalty.
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Senior Business Development Director
Plan and execute a territory-based field sales strategy. Drive growth through targeted long- and short-term account plans.
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Regional Sales Manager
Manage sales team within North America's Safety Assessment sales region to achieve sales and profit goals.
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Director
Partner with site leadership to achieve performance goals, develop staff, and deliver succession planning.
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Senior Director / General Manager
Lead a multi-functional team to ensure integrated operations. Collaborate with senior leadership to form plans, objectives, and policies.
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Executive Director
Lead a global, multidisciplinary team. Develop short and long-term strategic plans to maximize growth and profitability.
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Corporate Vice President
Provide leadership, direction, and advice to leadership and finance teams. Accountable for financial planning, directing, and controlling.
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About Charles River
Charles River is an early-stage Contract Research Organization (CRO). Here, we are passionate about our role in improving the quality of people’s lives. With 100 sites around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our clients’ unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies, hospitals, and academic institutions around the world.
Supporting your well-being
Your dedication and passion make a life-saving difference in lives around the world. We’re committed to providing you with benefits that elevate your quality of life.
Financial
- Earnings + incentives
- Retirement benefits
- Vacation + time away
- Recognition
- Employee assistance fund
Career
- Professional development opportunities
- Career development
- Awards
- Educational support
Health and wellness coverage
- Employee well-being support
- Family support programs
- Parental benefits + family formation benefits
- Work-life balance flexibility
Social and Community
- Culture of inclusion
- 11 employee resource groups (ERGs) with >3,000 members
- Opportunities for paid volunteer time off
- Community outreach + matching gift + engagement activities
About Charles River
Charles River is an early-stage Contract Research Organization (CRO). Here, we are passionate about our role in improving the quality of people’s lives. With 100 sites around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our clients’ unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies, hospitals, and academic institutions around the world.