Charles River Laboratories · 1 day ago
Associate Director of Quality -Rockville, MD
Rockville, MD
Full-time
Onsite
Lead/Staff, Director/Executive
8+ years expCharles River Laboratories is seeking an Associate Director of Quality to ensure quality performance and compliance across all strategic initiatives at their Rockville site. This role involves overseeing quality oversight, managing client-focused quality programs, and leading team development while maintaining compliance with regulatory standards.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Kathryn Crone
Responsibilities
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
Drives continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability
Actively participates in all recruiting efforts to secure, onboard, and develop new staff members
Perform Quality Control data and audit trail review
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
Qualification
Required
BS/BA required; MS preferred in scientific/technical discipline
Minimum of 8 years of experience in a Quality department leadership role within the biological and/or pharmaceutical industry
Excellent working knowledge and experience with the practical implementation of FDA, EMA and ICH regulations and guidelines
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
Preferred
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
Experience in TrackWise is preferrable
Company
Charles River Laboratories
At Charles River, we are guided by our strong purpose—to create healthier lives—which centers around the patients who rely on the therapeutics we help to develop, the animals in our care, to our planet, and to the passionate and skilled people who are at the heart of our organization and make it all possible.
10001+ employees
H1B Sponsorship
Charles River Laboratories has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (53)
2024 (37)
2023 (41)
2022 (41)
2021 (19)
2020 (19)
Funding
Current Stage
Public CompanyTotal Funding
$1.54BKey Investors
The Foundation for Chemistry Research and Initiatives
2024-06-11Grant· $1.3M
2021-03-23Post Ipo Debt· $1B
2019-10-21Post Ipo Debt· $500M
Leadership Team
James C. Foster
Chairman, President & Chief Executive Officer
C
Chuck Moran
Associate Director, Digital Experiences and Marketing Technology
Recent News
2026-01-09
Company data provided by crunchbase