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 Site Data Integrity (DI) Program Lead is responsible for ensuring the site operates under applicable regulatory policies and Charles River Laboratories corporate policies for documentation and data integrity to ensure consistency and continuity across all functional segments at the Charles River Laboratories Memphis site. The Data Integrity Program Lead is the site data integrity Subject Matter Expert and will be responsible to ensure adequate SOPs, processes and training and education for Data Integrity principles are in place and consistently implemented at the Memphis site for cGxP data, both in paper and/or electronic format. The Site DI Program Lead must exhibit ability to develop and sustain collaborative partnerships across all functions at the Memphis site to implement, mature, and sustain delivery to DI principles and requirements for all paper and electronic data.
- The Site DI Program Lead is the point person during regulatory inspections and internal and client audits for Data integrity and plays a major role to answer questions and demonstrate that necessary controls and required competencies are in place with respect to Data Integrity
- Ensures all new equipment and instrumentation is assessed appropriately and validated for its intended use and lifecycle management of data storage, review, and archival.
- Facilitate holistic data integrity reviews by partnering with cross-functional groups and stakeholders to conduct end to end business process assessments. Communicates actions, compliance gaps, and commitments to respective areas including the Site Director of Quality and reports on health of the DI Program at Memphis at monthly Quality Management Review governance meetings.
- Assist in sourcing, assessing, and recommending instrumentation and equipment for purchase; meets with vendors to discuss software capabilities with respect to 21CFR Part 11 compliance
- Provides periodic training to all operations to ensure awareness and compliance with data integrity for both paper and electronic records, including inspector interaction and good documentation practices
- Creates and updates procedures and processes as necessary to ensure operation’s awareness of the importance of regulatory requirements and expectations
- Routinely evaluates regulatory inspection documents and updates site procedures accordingly
- Aids in establishing user requirements for equipment
- Establishes and leads a data integrity program and partners with internal auditing teams to ensure internal audits at the site are assessed for compliance to documentation and data integrity standards, practices, and procedures.
- Perform all other related duties as assigned
Job Qualifications
- Bachelor’s degree in a science related field preferred
- Minimum 7 years’ experience in a regulated industry, or 5 years with related technical knowledge including data integrity related to quality control, knowledge of laboratory instrumentation and/or operations equipment and associated computer systems
- Advanced knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
- Thorough understanding of data integrity review, 21CFR Part 11 requirements, instrumentation compliance
- Strong technical knowledge and experience writing and reviewing investigations within a Quality Management System (TrackWise, preferred)
- Experience must include proven knowledge of Data Integrity (DI) related risk assessments and identification of mitigation actions
- Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint)
- Effective written, interpersonal, and presentation skills
- Ability to work on multiple projects simultaneously
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.
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!
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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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Operations Assistant
Helped track and guide operative improvements
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Project Coordinator
Managed critical facilities-related projects
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Procurement Lead
Managed procurement, shipping, inventory, and receiving
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Associate Manager – Operations Discovery
Drive continuous improvement projects and facility construction
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Saara Horttanainen, MBA Kuopio, Finland
Saara Horttanainen, MBA
Kuopio, Finland
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.