Senior Manager Quality Operations (Rockville, MD, US, 20850) presso Charles River Laboratories
Charles River Laboratories · Rockville, Stati Uniti d'America · Onsite
- Senior
- Ufficio in Rockville
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 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 is responsible to oversee execution and delivery from the following areas of the organization: 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 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 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
• Ensures only trained and experienced employees are involved in authoring and reviewing a controlled document
• Ensures current Good Manufacturing Practices (CGMPs) compliance for manufacturing of biological product, and compliance to 21 CFR Parts 210, 211 and 600 as applicable
• Monitors projects and help to 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
• Responsible for lot disposition and release of products
• 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. Contributes to data and information collection
• 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
• Additional duties as assigned, including a willingness to cross-train 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 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 preferrable
• 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
• Ability to be hands-on and detail oriented
Compensation Data
The pay range for this position is $140,000 - $160,000 per year. Please note that 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 Contract Development and Manufacturing Organization (CDMO) group supports biotechnology and pharmaceutical companies in advancing their 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 comprehensive analytical services and regulatory support. Whether clients need end-to-end development, standalone services, or insourced 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 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 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 (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.
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