Director Quality Operations
Salary undisclosed
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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 Director Quality Operations will be responsible for partnering with functional stakeholders at the site level to ensure Quality performance and Compliance is designed into, and maintained, across all strategic initiatives, Operations, functional support organizations, and execution of GMP activities at the Memphis site. The Director of Quality Operations is responsible to oversee execution and delivery from the following areas of the organization: Drug Product Disposition, Functional Organization Quality Oversight, On The Floor Quality, Raw Material Testing and Release as well as customer facing Quality program leads for each client in the CDMO- Memphis portfolio. The person filling this role will be responsible for the leadership, development and training of team members within their oversight as well as providing supportive leadership and strategic direction to operate with and maintain compliance to regulatory and industry quality standards in support of existing and new cellular therapy production.
Essential Duties And Responsibilities
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.
226324
Job Summary
The Director Quality Operations will be responsible for partnering with functional stakeholders at the site level to ensure Quality performance and Compliance is designed into, and maintained, across all strategic initiatives, Operations, functional support organizations, and execution of GMP activities at the Memphis site. The Director of Quality Operations is responsible to oversee execution and delivery from the following areas of the organization: Drug Product Disposition, Functional Organization Quality Oversight, On The Floor Quality, Raw Material Testing and Release as well as customer facing Quality program leads for each client in the CDMO- Memphis portfolio. The person filling this role will be responsible for the leadership, development and training of team members within their oversight as well as providing supportive leadership and strategic direction to operate with and maintain compliance to regulatory and industry quality standards in support of existing and new cellular therapy production.
Essential Duties And Responsibilities
- Responsible for Quality oversight of and to support the manufacturing and release of products within the Memphis site. Ensure that these activities are timely, efficient and productive while adhering to client’s requirements and operational and quality parameters.
- Build cross-functional relationships with relevant internal and external departments necessary to ensure sustained delivery of Quality System performance and KPIs.
- Prepare Revenue and Capex Budget as per spent analysis project. Ensure financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site.
- Maintain quality system controls for area of oversight to ensure no critical and major market complaints or audit findings.
- Build improved efficiencies by partnering with functional Leaders and Quality having a consistent presence on the floor.
- Ensure timely sampling, analysis and release of raw materials.
- Take appropriate steps to reduce waste and losses in Quality Operations processes and improve efficiency in ways of working.
- Supervise the Quality Program leads, who are responsible for client communications during the production process, to ensure customer service and program KPIs are met successfully.
- Provide leadership to and ensure necessary Quality oversight to areas within span of control.
- 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
- Effectively model, demonstrate and live the Charles River core values of Care, Lead, Own, and Collaborate
- 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.
- Perform all other related duties as assigned.
- Minimum Bachelors degree in life sciences or related field. An advanced degree in the life sciences is preferred, but not essential, based on experience
- Minimum 10 years of experience in a biologics, pharmaceutical, medical device, or related industry.
- Experience working in a GMP Biologics environment required.
- Minimum 5 years as a Leader with direct reports
- Complete competency with electronic document managements systems and other information management systems (QMS, ERP, LIMS,MES etc)
- Familiarity preferred with applicable regulatory requirements and compendia concerning cGMP manufacturing and testing of human cells (21CFR210, 211, 820 and 1271; Eudralex, USP, EP and ICH).
- Ability to maintain a high degree of accuracy and attention to detail.
- Familiarity with basic core QC areas including product/material stability, trending, comparability, qualification/ validation, compendia methods, etc.
- Excellent technical writing skills. Experience in drafting of Standard Operating Procedures (SOPs), protocols, reports, etc.
- Ability to problem solve and trouble shoot as necessary
- Understanding of immunology and the current field of immunotherapies
- Study design, data/ statistical analysis (e.g. use of SigmaPlot, JMP and Excel), reporting results in both written and oral format (presentation)
- Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively.
- Outstanding verbal and written communication skills.
- Proficiency in Microsoft Office (Word, Excel, Outlook, etc.) is essential.
- Compliance with cGMP/ GLP regulations as well as excellent documentation skills in order to complete paperwork
- Understanding/familiarity with relevant FDA, EMA, ICH, USP and EP guidelines and regulations associated with the quality control of biologic/cell therapies.
- Experience preferred with CDMO business and/or gene-modification modalities, cell-based gene therapies.
- ISO Lead Auditor training, desirable.
- Certified Quality Engineer (ASQ), desirable
- Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively
- Demonstrated project management skills
- Demonstrated management and collaboration skills
- Outstanding verbal and written communication skills
- Complete competency with electronic document managements systems and other information management systems
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.
226324