Charles River
Job Summary
The Senior Manager Quality Operations is 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 Rockville site. The candidate filling this role oversees execution and delivery from the following areas: Functional Organization Quality Oversight, On the Floor Quality, QC testing for in-process, stability, and release as well as customer facing Quality program leads for each client in the CDMO-Rockville portfolio. The person in this role leads, develops and trains team members within their oversight and provides supportive leadership and strategic direction to maintain compliance with regulatory and industry quality standards in support of existing and new cell-based gene therapy production.
Key Responsibilities and Duties
Provides leadership for creating a culture of Quality and Compliance that is integrated with end-to-end supply.
Works with project teams and department staff to provide guidance and strong quality leadership.
Manages and schedules Quality Assurance personnel for CGMP operations support.
Monitors projects and facilitates issue resolution or escalation to ensure on-time delivery of client projects with effective risk mitigation and stakeholder communication.
Collaborates with manufacturing and technical teams supporting Fill/Finish to identify root causes and determine corrective and preventive actions for investigations.
Manages the review (audit) of batch production records, EM test reports, cleaning records, material release documentation and quality control test reports; prepares BPR audit reports and follows up with task owners to close deficiencies.
Ensures QA batch record review and lot release deliverables are client-focused, results-oriented, performance-driven, and compliant with internal and external requirements.
Reviews and approves batch production and development records in support of GMP-regulated operations.
Reviews and approves ancillary facility and equipment records in support of GMP regulators.
Reviews and approves assay qualification, equipment, and stability protocols and reports.
Provides technical expertise in investigations and makes recommendations for data collection required for quality events; contributes to data collection.
Alerts management to critical issues impacting manufacturing objectives and timelines, and offers achievable solutions.
Manages the walkthrough program in GMP Manufacturing, quality control testing, storage and material receiving area for compliance to approved procedures.
Oversees revision, issuance and tracking of controlled documents used to support bulk and sterile fill biologic products.
Manages Quality Risk Management during qualification and identification of quality events.
Drives a culture of continuous improvement and operational excellence through self-detecting and self-correcting processes, fostering ownership and accountability.
Additional duties as assigned, including willingness to cross-train and support other Quality areas such as Quality Systems, Training, Document Control, and Supplier Quality.
Job Qualifications
BS required; MS preferred in scientific/technical discipline.
Minimum of 5 years of experience in a Quality department leadership role within the biological and/or pharmaceutical industry.
Experience preferred with CDMO business and/or gene-modification modalities, cell-based gene therapies.
Experience in reviewing quality control test reports and batch production records for clinical and commercial pharmaceutical/biopharmaceutical manufacturing.
Excellent working knowledge and experience with the practical implementation of FDA, EMA and ICH regulations and guidelines.
Experience in TrackWise is preferable.
Exceptional interpersonal and communication skills; ability to influence, negotiate and resolve challenges.
Strong organizational skills with the ability to prioritize and manage complex processes/projects.
Ability to define problems, collect data, and draw valid conclusions.
Extensive experience writing and managing investigations and risk assessments.
Previous experience as an auditor for internal and vendor audits.
Hands-on and detail-oriented.
Compensation Data The pay range for this position is $140,000 - $160,000 per year. Salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
About Charles River’s CDMO Services With over 20 years of experience and industry-leading expertise, Charles River’s cell and gene therapy CDMO group supports biotechnology and pharmaceutical companies in advancing complex programs from early development through commercialization. Our integrated, phase-appropriate CDMO capabilities—including plasmid DNA, viral vector, and cell therapy manufacturing—enable seamless development and faster timelines. With centers of excellence in the US and UK, we offer GMP-compliant and research-grade solutions, along with analytical services and regulatory support. Our CDMO team provides custom solutions to meet evolving program needs. From process development in Hanover to viral vector manufacturing in Rockville, large-scale cell therapy production in Memphis, and plasmid DNA services in Keele, we simplify the supply chain and accelerate cell and gene therapy breakthroughs.
About Charles River Charles River is an early-stage contract research organization (CRO). We provide a diverse portfolio of discovery and safety assessment services, GLP and non-GLP, to support clients from target identification through preclinical development. We also provide products and services to support clinical laboratory testing and manufacturing activities. Our broad portfolio enables a flexible drug development model to reduce costs and accelerate speed to market.
With over 20,000 employees in 110 facilities across 20 countries, we coordinate worldwide resources to resolve clients’ challenges. Our client base includes global pharmaceutical and biotechnology companies, government agencies, hospitals and academic institutions.
We are committed to improving the quality of people’s lives and to providing benefits that elevate your quality of life. This may include bonus/incentives, 401K, paid time off, stock purchase program, health and wellness coverage, and work-life balance flexibility.
Charles River is an equal opportunity employer and provides equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, disability, family status, pregnancy, military or veteran status, or any other characteristic protected by law. It is unlawful in some states to require or administer a lie detector test as a condition of employment.
If you need special assistance due to a disability to complete any forms or participate in the resume submission process, please contact our Human Resources team at crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only.
For more information, please visit www.criver.com.
Nearest Major Market:
Washington DC
Job Segment:
Pharmaceutical, Supply Chain Manager, Operations Manager, Quality Assurance, Supply Chain, Science, Operations, Technology
#J-18808-Ljbffr
The Senior Manager Quality Operations is 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 Rockville site. The candidate filling this role oversees execution and delivery from the following areas: Functional Organization Quality Oversight, On the Floor Quality, QC testing for in-process, stability, and release as well as customer facing Quality program leads for each client in the CDMO-Rockville portfolio. The person in this role leads, develops and trains team members within their oversight and provides supportive leadership and strategic direction to maintain compliance with regulatory and industry quality standards in support of existing and new cell-based gene therapy production.
Key Responsibilities and Duties
Provides leadership for creating a culture of Quality and Compliance that is integrated with end-to-end supply.
Works with project teams and department staff to provide guidance and strong quality leadership.
Manages and schedules Quality Assurance personnel for CGMP operations support.
Monitors projects and facilitates issue resolution or escalation to ensure on-time delivery of client projects with effective risk mitigation and stakeholder communication.
Collaborates with manufacturing and technical teams supporting Fill/Finish to identify root causes and determine corrective and preventive actions for investigations.
Manages the review (audit) of batch production records, EM test reports, cleaning records, material release documentation and quality control test reports; prepares BPR audit reports and follows up with task owners to close deficiencies.
Ensures QA batch record review and lot release deliverables are client-focused, results-oriented, performance-driven, and compliant with internal and external requirements.
Reviews and approves batch production and development records in support of GMP-regulated operations.
Reviews and approves ancillary facility and equipment records in support of GMP regulators.
Reviews and approves assay qualification, equipment, and stability protocols and reports.
Provides technical expertise in investigations and makes recommendations for data collection required for quality events; contributes to data collection.
Alerts management to critical issues impacting manufacturing objectives and timelines, and offers achievable solutions.
Manages the walkthrough program in GMP Manufacturing, quality control testing, storage and material receiving area for compliance to approved procedures.
Oversees revision, issuance and tracking of controlled documents used to support bulk and sterile fill biologic products.
Manages Quality Risk Management during qualification and identification of quality events.
Drives a culture of continuous improvement and operational excellence through self-detecting and self-correcting processes, fostering ownership and accountability.
Additional duties as assigned, including willingness to cross-train and support other Quality areas such as Quality Systems, Training, Document Control, and Supplier Quality.
Job Qualifications
BS required; MS preferred in scientific/technical discipline.
Minimum of 5 years of experience in a Quality department leadership role within the biological and/or pharmaceutical industry.
Experience preferred with CDMO business and/or gene-modification modalities, cell-based gene therapies.
Experience in reviewing quality control test reports and batch production records for clinical and commercial pharmaceutical/biopharmaceutical manufacturing.
Excellent working knowledge and experience with the practical implementation of FDA, EMA and ICH regulations and guidelines.
Experience in TrackWise is preferable.
Exceptional interpersonal and communication skills; ability to influence, negotiate and resolve challenges.
Strong organizational skills with the ability to prioritize and manage complex processes/projects.
Ability to define problems, collect data, and draw valid conclusions.
Extensive experience writing and managing investigations and risk assessments.
Previous experience as an auditor for internal and vendor audits.
Hands-on and detail-oriented.
Compensation Data The pay range for this position is $140,000 - $160,000 per year. Salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
About Charles River’s CDMO Services With over 20 years of experience and industry-leading expertise, Charles River’s cell and gene therapy CDMO group supports biotechnology and pharmaceutical companies in advancing complex programs from early development through commercialization. Our integrated, phase-appropriate CDMO capabilities—including plasmid DNA, viral vector, and cell therapy manufacturing—enable seamless development and faster timelines. With centers of excellence in the US and UK, we offer GMP-compliant and research-grade solutions, along with analytical services and regulatory support. Our CDMO team provides custom solutions to meet evolving program needs. From process development in Hanover to viral vector manufacturing in Rockville, large-scale cell therapy production in Memphis, and plasmid DNA services in Keele, we simplify the supply chain and accelerate cell and gene therapy breakthroughs.
About Charles River Charles River is an early-stage contract research organization (CRO). We provide a diverse portfolio of discovery and safety assessment services, GLP and non-GLP, to support clients from target identification through preclinical development. We also provide products and services to support clinical laboratory testing and manufacturing activities. Our broad portfolio enables a flexible drug development model to reduce costs and accelerate speed to market.
With over 20,000 employees in 110 facilities across 20 countries, we coordinate worldwide resources to resolve clients’ challenges. Our client base includes global pharmaceutical and biotechnology companies, government agencies, hospitals and academic institutions.
We are committed to improving the quality of people’s lives and to providing benefits that elevate your quality of life. This may include bonus/incentives, 401K, paid time off, stock purchase program, health and wellness coverage, and work-life balance flexibility.
Charles River is an equal opportunity employer and provides equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, disability, family status, pregnancy, military or veteran status, or any other characteristic protected by law. It is unlawful in some states to require or administer a lie detector test as a condition of employment.
If you need special assistance due to a disability to complete any forms or participate in the resume submission process, please contact our Human Resources team at crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only.
For more information, please visit www.criver.com.
Nearest Major Market:
Washington DC
Job Segment:
Pharmaceutical, Supply Chain Manager, Operations Manager, Quality Assurance, Supply Chain, Science, Operations, Technology
#J-18808-Ljbffr