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 Senior Director Global Head of Biologics Testing Quality will provide direction and leadership as regulatory Subject Matter Expert in Biologics Testing Quality Systems and provide guidance and support for multisite Biologics Testing (BLX) compliance program designs and/or QA/QC activities. The individual will have oversight of various business unit QA/QC teams to establish/improve the Quality Units regulatory knowledge and either establish or improve quality systems and processes specific to the testing platforms supporting GMP activities while ensuring compliance with all appropriate worldwide governmental regulatory agencies (FDA, EMA, HPRA, etc.) and corporate policies to avoid any business interruption. This leader will be a key contributor to engaging clients and new customers in establishing our Quality organization support and protocols.
Essential Duties and Responsibilities
⦁ Provide input into the development of regulatory strategy, objectives, and processes across the Biologics Testing Business Units and with CDMO/Microbial business partners that fundamentally raise the importance of quality/compliance within the organization. Work directly with senior corporate operations management teams to ensure regulatory compliance and consistency with Charles River policies and procedures.
⦁ Oversight of Biologics Testing QA Business Units; assess that Quality Management Systems (QMS) meet regulatory requirements and that processes and systems are efficient and effective.
⦁ Interact with clients, regulators and/or industry experts to represent CRL interests, as appropriate.
⦁ Serve as the coordination contact for governmental regulatory agencies (i.e. FDA, HPRA, EMA and other agencies) relating to such matters.
⦁ Build an environment to optimize employee compliance and add quality culture values to the organization by actively providing guidance or input into business team meetings.
⦁ Provide assistance with the development and implementation of global GMP training programs to provide compliance managers and staff in designated staff functions and/or businesses with the knowledge and experience to advance the strategic objectives of the Corporate Compliance Program. Identify emerging issues and the training experiences necessary to enable the staff in addressing these issues at the various global sites.
⦁ Provide input and guidance for Computer System Validation activities, ensuring the strategies and processes are aligned with corporate regulatory policies and are aligned globally from a quality perspective.
⦁ Foster a culture of continuous improvement within the QA organization.
⦁ Recruit, develop, and lead high-performing QA teams, fostering/creating a positive and collaborative team culture in support of the CRL Values of Lead, Own, Collaborate and Care
⦁ Collaborate with stakeholders, implement test automation strategies, monitor performance metrics, and ensure regulatory compliance to drive effective quality assurance processes.
⦁ Perform a continuing program of review and analysis of QA functions and findings. Track and assess all critical audit findings from internal and external sources.
⦁ Direct due diligence assessments of potential business acquisitions and dispositions and prepare recommendations to executive management.
⦁ Review commitments to clients and domestic and international regulatory agencies, including responses to domestic and international regulatory inspection findings, Warning Letters, and untitled letters, to assure corrective and preventive actions have been fulfilled.
⦁ Coordinate the development and/or revision of harmonized quality assurance procedures affecting multiple sites.
⦁ Serve as consultant to all company divisions on related quality and regulatory issues.
⦁ Provide regulatory guidance to internal departments for the development of new products, test methodology, new facility construction, and new manufacturing process.
⦁ Develop short- and long-range operating objectives, organizational structure, staffing requirements and succession plans.
⦁ Perform all other related duties as assigned.
Job Qualifications
⦁ Education: Bachelor’s degree (B.A. /B.S.) or equivalent in scientific discipline or related field. Advanced degree in biological sciences, pharmaceutical science or computer sciences preferred.
⦁ Experience: Fifteen (15) or more years related experience in a pharmaceutical and/or biotechnology-related industry having direct responsibility for QA/ Quality Control/Regulatory Affairs. Minimum of 5 years oversight of multiple Global Operations sites.
⦁ Ability to build strong relationships and collaborate effectively across departments.
⦁ Experience with Strategic M&A integrations
⦁ In-depth knowledge of GMP, governmental regulations, and other relevant quality standards.
⦁ An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
⦁ Certification/Licensure: None
⦁ Travel requirements: 20%- 30% domestic and international
⦁ Other: In-depth knowledge of 21 CFR Parts 11, 210, 211, 600 series, 800 series and related guidance documents (US and OUS) as well as FDA and USDA regulations and International Council on Harmonization (ICH) guidelines. Excellent verbal and written communications skills required.
PHYSICAL DEMANDS:
⦁ Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer.
⦁ Must regularly communicate with employees/customers; must be able to exchange accurate information.
⦁ Must occasionally move about inside the office to access file cabinets, office machinery, etc.
WORK ENVIRONMENT:
⦁ General office working conditions, the noise level in the work environment is usually quiet.
Comments:
⦁ This position requires regular domestic and international travel.
Compensation Data
The base pay range for this position is 200,000.00 – 240,000.00. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.
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 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.
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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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Sr. UX/UI Designer
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Animal Care Technologist I-IV
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Veterinary Technician
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Team Leader / Supervisor
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Intern Level I
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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
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Biomanufacturing Lead / Specialist
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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
Utlise knowledge of laboratory animal medicine to optimise the scientific objectives of animal research protocols.
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Principal Veterinarian / Associate Director
Conduct veterinary consultations, make treatment recommendations, communicate with study directors, and follow cases through to 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 specialised 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
Help analyse 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, Operation
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 specialised 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 specialised 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, mutidisciplinary team. Develop short and long-term strategic plans tp maximise 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 Organisation (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
- Holidays + time away
- Recognition
- Employee Assistance
Career
- Professional development opportunities
- Career development
- Awards
- Educational support
Health & wellness provision
- Employee well-being support
- Family Support Assistance
- 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 Organisation (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.