Charles River Laboratories
Overview
Join to apply for the
Senior Manager Quality Operations
role at
Charles River Laboratories .
Charles River is an early-stage contract research organization (CRO) supporting drug development and manufacturing. We are committed to providing benefits that elevate quality of life, and we strive to improve health and well-being across the globe.
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 will oversee execution and delivery from: 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 role includes leadership, development and training of team members within their oversight and providing strategic direction to operate in compliance with regulatory and industry quality standards in support of existing and new cell-based gene therapy production.
Key Responsibilities And Duties
Provides the necessary leadership for creating a culture of Quality and Compliance that is well integrated and supportive of end-to-end supply
Works with project teams and individual departmental staff to provide guidance and strong quality leadership
Manages and schedules Quality Assurance personnel for support of CGMP operations
Monitors projects and helps resolve issues or escalate appropriately to ensure on-time delivery of all client projects with management of effective risk mitigation plans and stakeholder communication
Collaborates with full range of personnel in manufacturing and technical work teams that support Fill/Finish to identify root cause of a problem and determine appropriate corrective action and preventive action for investigations
Manages the review (audit) of batch production records, EM test reports, cleaning records, material release documentation and quality control test reports, prepare BPR audit reports and follow-up with task owners for the completion of the identified deficiencies
Ensures that QA batch record review and lot release deliverables are client focused, results oriented, performance driven, and in compliance with all applicable 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 regulated operations
Reviews and approves assay qualification, equipment, and stability protocols and reports
Provides technical expertise in conducting investigations and making recommendations for targeted data and information collection as required for quality events
Alerts management of critical issues that have significant impact to manufacturing objectives and timelines, while providing a range of achievable solutions
Manages the walkthrough program in GMP Manufacturing, quality control testing, storage and material receiving area for compliance to approved procedure
Oversees the revision, issuance and tracking of controlled documents used to support the bulk and sterile fill biologic products
Manages Quality Risk Management process during the qualification and identification of quality events
Drives continuous improvement and operational excellence culture thru self-detecting and self-correcting processes and systems and instilling strong ownership and accountability
Additional duties as assigned, including cross-training and support in other functional 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 skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy
Exceptional verbal and written communication skills to all organization levels and clients
Strong organizational skills; able to prioritize and manage through complex processes/projects
Ability to define problems, collect data, and draw valid conclusions
Extensive experience with 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 experience, skills, education, certifications, and location.
About Charles River CDMO Services With over 20 years of experience, Charles River’s cell and gene therapy CDMO group supports biotechnology and pharmaceutical companies from development through commercialization. Our capabilities include plasmid DNA, viral vector, and cell therapy manufacturing, with centers of excellence in the US and UK. We offer GMP-compliant and research-grade solutions, analytical services, and regulatory support.
About Charles River Charles River is an early-stage contract research organization (CRO). We provide a broad portfolio of discovery and safety assessment services, GLP and non-GLP, to support clients from target identification through preclinical development, along with clinical laboratory testing needs and manufacturing activities. We have 20,000+ employees across 110 facilities in 20+ countries, serving global clients including pharmaceutical and biotechnology companies, government agencies, hospitals and academic institutions.
Equal Employment Opportunity Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.
It is unlawful in some states to require or administer a lie detector test as a condition of employment. If you need accommodations due to a disability to complete any forms or participate in the resume submission process, please contact a member of our Human Resources team at crrecruitment_US@crl.com.
For more information, please visit www.criver.com.
Referrals increase your chances of interviewing at Charles River Laboratories.
Job Location and Additional Notes Chantilly, VA; Washington DC-Baltimore Area; Reston, VA; Rockville, MD; other locations as applicable. Posted recently with salary ranges shown in related postings.
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Join to apply for the
Senior Manager Quality Operations
role at
Charles River Laboratories .
Charles River is an early-stage contract research organization (CRO) supporting drug development and manufacturing. We are committed to providing benefits that elevate quality of life, and we strive to improve health and well-being across the globe.
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 will oversee execution and delivery from: 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 role includes leadership, development and training of team members within their oversight and providing strategic direction to operate in compliance with regulatory and industry quality standards in support of existing and new cell-based gene therapy production.
Key Responsibilities And Duties
Provides the necessary leadership for creating a culture of Quality and Compliance that is well integrated and supportive of end-to-end supply
Works with project teams and individual departmental staff to provide guidance and strong quality leadership
Manages and schedules Quality Assurance personnel for support of CGMP operations
Monitors projects and helps resolve issues or escalate appropriately to ensure on-time delivery of all client projects with management of effective risk mitigation plans and stakeholder communication
Collaborates with full range of personnel in manufacturing and technical work teams that support Fill/Finish to identify root cause of a problem and determine appropriate corrective action and preventive action for investigations
Manages the review (audit) of batch production records, EM test reports, cleaning records, material release documentation and quality control test reports, prepare BPR audit reports and follow-up with task owners for the completion of the identified deficiencies
Ensures that QA batch record review and lot release deliverables are client focused, results oriented, performance driven, and in compliance with all applicable 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 regulated operations
Reviews and approves assay qualification, equipment, and stability protocols and reports
Provides technical expertise in conducting investigations and making recommendations for targeted data and information collection as required for quality events
Alerts management of critical issues that have significant impact to manufacturing objectives and timelines, while providing a range of achievable solutions
Manages the walkthrough program in GMP Manufacturing, quality control testing, storage and material receiving area for compliance to approved procedure
Oversees the revision, issuance and tracking of controlled documents used to support the bulk and sterile fill biologic products
Manages Quality Risk Management process during the qualification and identification of quality events
Drives continuous improvement and operational excellence culture thru self-detecting and self-correcting processes and systems and instilling strong ownership and accountability
Additional duties as assigned, including cross-training and support in other functional 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 skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy
Exceptional verbal and written communication skills to all organization levels and clients
Strong organizational skills; able to prioritize and manage through complex processes/projects
Ability to define problems, collect data, and draw valid conclusions
Extensive experience with 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 experience, skills, education, certifications, and location.
About Charles River CDMO Services With over 20 years of experience, Charles River’s cell and gene therapy CDMO group supports biotechnology and pharmaceutical companies from development through commercialization. Our capabilities include plasmid DNA, viral vector, and cell therapy manufacturing, with centers of excellence in the US and UK. We offer GMP-compliant and research-grade solutions, analytical services, and regulatory support.
About Charles River Charles River is an early-stage contract research organization (CRO). We provide a broad portfolio of discovery and safety assessment services, GLP and non-GLP, to support clients from target identification through preclinical development, along with clinical laboratory testing needs and manufacturing activities. We have 20,000+ employees across 110 facilities in 20+ countries, serving global clients including pharmaceutical and biotechnology companies, government agencies, hospitals and academic institutions.
Equal Employment Opportunity Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.
It is unlawful in some states to require or administer a lie detector test as a condition of employment. If you need accommodations due to a disability to complete any forms or participate in the resume submission process, please contact a member of our Human Resources team at crrecruitment_US@crl.com.
For more information, please visit www.criver.com.
Referrals increase your chances of interviewing at Charles River Laboratories.
Job Location and Additional Notes Chantilly, VA; Washington DC-Baltimore Area; Reston, VA; Rockville, MD; other locations as applicable. Posted recently with salary ranges shown in related postings.
#J-18808-Ljbffr