Associate Director Quality

Job Summary

Associate Director Quality at Charles River Laboratories. The role partners with functional stakeholders at the site level to ensure quality performance and compliance are integrated and maintained across all strategic initiatives, operations, and GMP activities at the Rockville site. The Associate Director leads the execution and delivery of functional quality oversight, on‑floor quality, and customer‑facing quality program leads for each client in the CDMO‑Rockville portfolio, while providing strategic direction to maintain compliance with regulatory and industry quality standards for existing and new cell‑based gene therapy production.

• Monitors projects and resolves issues or escalates appropriately to ensure on‑time delivery of all client projects with effective risk mitigation plans and stakeholder communication.
• Collaborates with 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; prepares BPR audit reports and follows up with task owners to complete identified deficiencies.
• Ensures 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 areas for compliance to approved procedures.
• 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 through self‑detecting and self‑correcting processes and systems, instilling strong ownership and accountability.
• Actively participates in all recruiting efforts to secure, onboard, and develop new staff members.
• Performs quality control data and audit trail review.
• Additional duties as assigned, including cross‑training and support in other functional quality areas such as quality systems, training, document control, and supplier quality.

• BS/BA required; MS preferred in a scientific/technical discipline.
• Minimum of 8 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 of FDA, EMA, and ICH regulations and guidelines and their practical implementation.
• Experience in Track Wise 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 at all organization levels and to clients.
• Strong organizational skills; able to prioritize and manage through complex processes and 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…