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 strategic global role will identify and drive Quality Control Testing and overall Quality Optimization strategic initiatives for they Charles River Laboratories’ CDMO business unit. Specifically, the individual filling this role will be responsible to build customer value in two ways: ensuring all CDMO sites have appropriate QC testing abilities locally that satisfies CRL, customer and GDP standard and through continuous improvement projects and best practice sharing drive harmonization throughout the Quality function at all CDMO sites. This role requires collaboration, consultation, and support to CRL CDMO teams and clients to ensure quality processes and customer value are delivered throughout the different locations and product/services offered in CRL’s CDMO business line.
This role will involve analyzing data, building business cases, collaborating with cross-functional teams, and driving continuous improvement initiatives to ensure high-quality value for our customers. A key aspect of this role is to ensure that the business meets regulatory quality standards across the global while driving synergies, time and cost savings in all the CDMO locations.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Develop and maintain a robust knowledge of CRL network capabilities by serving as a connector across CDMO sites to identify best practices, harmonize quality approaches and measurements, and drive network-wide improvements.
• Stay up to date on Quality trends within the CDMO Industry and Pharma at large.
• Influence business leaders to push projects that build capabilities in quality and create harmonization
• Build business cases for project and change justification
• Track project health of all QC Testing and Harmonization projects until ROI has been realized
• Maintain a network of CRL Quality and Operational Associates to help identify and drive projects at different sites
• Harmonize Quality process and language across all CRL CDMO sites
• Serves as 1st level Subject Matter Expert for all new QC testing requirements and process improvements
• Support Executive Director of CDMO Quality as champion of continuous improvement and operational excellence to align organization with industry best practices, and where appropriate, mentoring cross-functional teams to advance continuous improvement mindsets and projects.
• Collaborates with Regulatory and Compliance teams when needed on Audit and Inspections
• Develops and reports on CDMO wide Quality Metrics
• Consults with Global and Site Quality Teams to identify training needs and content
• Provide support to sites during regulatory and client inspections/audits
• Participate in Regulatory Affairs and Compliance projects and programs.
• Drive and ensure adherence to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
• Perform all other related duties as assigned.
Job Qualifications
• Bachelor’s degree (B.A./B.S.) or equivalent
• Three to five years’ experience working within Quality at a pharmaceutical and/or biotechnology company
• Detail-oriented, with the ability to manage complex problems, maintain a high level of confidentiality, require minimal direction and ability to work within a team environment
• Ability to manage, prioritize, and multi-task various responsibilities
• Ability to deliver information in a digestible format at various levels
• Ability to travel to directly support sites as needs arise (approximately 30% of time)
• Five plus years of experience using and improving common CDMO systems like ERPs, MES, LIMS, LES, DSS(Decision Support Systems), QMS and other tools
• Have a proven history of driving continuous improvement projects and culture
• Lean Six Sigma Black Belt or Master Black Belt certified from one of the following organizations: CSSC, IASSC, ASQ, or SSGI
• At least five years’ experience interacting with FDA and EU Health Authority
• MBA or Masters in Quality Systems and Improvement Management preferred
• First hand Knowledge of SAP, Labware 7, MODA, Kneat, SmartSolve and Trackwise preferred
Compensation Data
The pay range for this position is $120,000-130,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.
About Cognate BioServices
Cognate BioServices, Inc., a Charles River Company, is the premier commercial-ready CDMO for cell and gene therapy needs. We are a dynamic, results-driven organization focused on providing the broadest range of expertise across the various cell types and technologies used in the commercialization of cell & gene therapies for regenerative medicine, cellular immunotherapy, and advanced cell therapy companies, organizations, and institutions.
We offer a unique combination of standard and custom services to companies across all points of clinical and commercial development. Our development and manufacturing services are focused on clients seeking rapid development of products from clinical studies into commercial manufacturing, with a unique capacity to handle all aspects of scale-up and commercial readiness.
Cognate leverages the combined know-how and expertise of its business, scientific, and technical teams to successfully develop and manufacture autologous and allogenic products across multiple cell-based technology platforms from start to finish, for you and your patients.
For more information, visit www.cognatebioservices.com
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 [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 interview process by meeting with a 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 and better understand how we foster a sense of belonging at Charles River.
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 interview process by meeting with a 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 and better understand how we foster a sense of belonging at Charles River. 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 belonging
- 11 employee resource groups (ERGs) with >4,000 members, where all employees are welcome
- 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.