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Associate Director, Quality Assurance

1 month ago

Philadelphia, United States Proclinical Staffing Full time

Associate Director, Quality Assurance - Permanent - Philadelphia, PA Proclinical is working alongside a pharmaceutical company seeking an Associate Director, Quality Assurance to join their growing team Primary Responsibilities: The successful candidate will lead a team of quality professionals, supporting the routine release of raw materials, critical reagents, and TIL Drug Product materials for clinical and commercial operations. They will ensure that quality assurance processes are timely and compliant. Skills & Requirements: Degree in science; advanced degree is a plus. Experience in the pharmaceutical/biotech industry, particularly in cell therapy or biologics. Supervisory experience in a commercial manufacturing environment. Strong interpersonal, verbal, and written communication skills. Experience with label issuance for final drug products. Proficient in troubleshooting, investigations, and problem-solving. Knowledge of GMPs and Health Authority standards in the US and Europe. Ability to manage multiple projects simultaneously. Comfortable in a fast-paced environment with changing priorities. Professional influence and negotiation skills. Responsibilities: Lead the QA team for the release of raw materials, components, and drug products. Oversee QA release of internal manufacturing and materials. Escalate significant quality issues promptly. Manage batch record review and lot closure. Approve documentation from third-party warehouses. Handle lot release and disposition activities. Support raw material, component, and kit release for manufacturing. Lead or support investigations of deviations and nonconforming events. Drive continuous improvements in QA processes. Support change controls and quality system records. Develop and establish SOPs for product release. Approve label specifications and review quality records. Maintain training matrix for the release team. Manage final product label issuance. Propose and implement procedural changes to improve product quality. Ensure knowledge sharing and collaborative troubleshooting. Support audits as required. Track and report on quality release metrics. Perform other duties as assigned. #J-18808-Ljbffr