What are the responsibilities and job description for the Product Quality Lead position at Charles River Laboratories?
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 Product Quality Lead will be the primary point of contact for the customer on all matters related to Quality Assurance and Quality Control. This position requires a deep CDMO/GMP quality knowledge, highly motivated, tenacious, self-starter who can assimilate new information quickly and enjoys working closely with others within a fast-paced project execution environment. Responsible for contributing to key functional, tactical, and operational aspects of the Memphis CDMO site. This includes approval & oversight of QC activities associated with exceptions, CAPA, deviations, Analytical instrument validation, change control requests, and other documentation related to QA operations. The individual will perform activities in support of dispositioning product and/or raw materials while ensuring compliance with directives and procedures, customer requirements, and regulatory standards.
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 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.
For more information, please visit www.criver.com.
226848
Job Summary
The Product Quality Lead will be the primary point of contact for the customer on all matters related to Quality Assurance and Quality Control. This position requires a deep CDMO/GMP quality knowledge, highly motivated, tenacious, self-starter who can assimilate new information quickly and enjoys working closely with others within a fast-paced project execution environment. Responsible for contributing to key functional, tactical, and operational aspects of the Memphis CDMO site. This includes approval & oversight of QC activities associated with exceptions, CAPA, deviations, Analytical instrument validation, change control requests, and other documentation related to QA operations. The individual will perform activities in support of dispositioning product and/or raw materials while ensuring compliance with directives and procedures, customer requirements, and regulatory standards.
- Develop and shape a best in class Quality experience for clients by executing timely and effective responses and corrective actions for quality topics
- Ensure strategic alignment with deliverables by leading execution efforts across key internal and external stakeholders
- Coordinate inputs from clients and Quality Operations functional team from work statement approval through to project completion
- Ensure timely awareness of quality agreements to key functional representatives and Quality Operations function
- Provide specific technical knowledge for the Quality Unit organization (participating on investigations, studies, and trending evaluation as well as innovation and continuous improvements projects)
- Delegate tasks within the Quality Operations function and drive progress to completion during execution to the required standard (internal and customer’s) and ensure on-time completion of Quality deliverables
- Attend and participate in client meetings, Tech Transfers, and other related meetings in support of client projects
- Collaborate to ensure that tasks are prioritized, completed on time, and communicated in an effective and timely manner
- Perform, review, approve (as applicable), and follow up tech transfers and methods validation documentations related to the different customer´s projects
- Perform the monitoring of the process from the quality perspective
- Supports Lot Disposition for the batch release (Deviation, Change Control)
- Review and approve (as applicable) Stability Protocols and Reports.
- Develop and implement reporting to track key metrics quickly identifying trends to drive proactive resolution in compliance with internal and external guidelines, standards, and regulations
- Build trust and influence within different departments of the operation by being a top Quality advisor to Operators and Clients.
- Participate in client and regulatory audits
- Actively mentor other quality professionals at CRL to deepen business and quality acumen
- Effectively model, demonstrate and live an employee-focused leadership style that prioritizes compliance, respectful and professional cross departmental collaboration, accountability, and the well-being, personal, and career development of each employee.
- Lead, coach and mentor individuals from all parts of the organization with varying levels of experience. Be a valued resource for the site in all matters related quality and compliance.
- Minimum 10 years of related industry experience and 5 years of leadership experience
- 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
- Strong client-facing interpersonal skills coupled with a concern for impact
- Strong time management and organizational skills
- Excellent written and oral communication skills both internal and external
- Able to manage multiple priorities and demonstrate self-control
- Ability to resolve conflict within project teams
- Exhibit good leadership skills
- Strong attention to detail
- Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community
- Proficiency in Microsoft Office (Word, Excel, Outlook, etc.) is essential.
- Understanding/familiarity with relevant FDA, EMA, ICH, USP and EP guidelines and regulations associated with the quality control of biologic/cell therapies.
- 3 or more years’ experience being a super user of Trackwise Digital, SmartSolve, Maximo, and other Quality related systems
- 2 plus years in developing and maintaining budgets at a department level
- Experience preferred with CDMO business and/or gene-modification modalities, cell-based gene therapies.
- ISO Lead Auditor training, desirable.
- Certified Quality Engineer (ASQ), desirable
- 3 plus years leading projects that involve multiple departments and outside organizations
- PMP certified is a plus
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 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.
For more information, please visit www.criver.com.
226848
Salary : $160,000 - $180,000
