Laura Leclair
- Role
- Qa Manager, Cell Therapy Operations at Lonza
- Location
- Baltimore City County, MD, US
- LinkedIn followers
- 500 followers
About Laura Leclair
MEMBER OF QA MANAGEMENT TEAM | DRIVES cGMP + GLP COMPLIANCE | EXPERIENCED IN CELL THERAPY…
Experience
Qa Manager, Cell Therapy Operations
Dec 2015 — Present
My position is responsible for ensuring cGMP compliance during the production, testing, release and distribution of clinical products. I am also responsible for the supporting regulatory or customer inspections, representing the Cell Therapy Quality Assurance Department. I manage a team of six responsible for providing QA support on project teams, acting as client interface and otherwise ensuring that quality requirements are met, as well as oversee batch record and APS development, deviations, OOS, CAPAs, technical investigations and batch release related to clinical cell therapy products. • Manage the Quality Assurance Cell Therapy Operation Team. • Develops and plans departmental goals, establishes timelines and monitors progress and completion. • Develop and approve cGMP documents including, but not limited to, SOPs, batch records and specifications. • Auditing of both internal departments and suppliers as necessary. • Managing Complaint handling and ensuring that quality related complaints are investigated and resolved. • Supports regulatory or client audits as Cell Therapy subject matter expert. • Ensure deviations, major investigations and CAPAs are completed. • Assesses facility and quality systems’ state of compliance with internal requirements and appropriate regulations, and participates in the development of action plans to correct deficiencies and improve quality processes. • Manages the evaluation of batch records and corresponding component and test records to ensure completeness. • Evaluate requirements for starting materials, packaging materials, bulk and final products. • Ensures that the required initial and continuing training of QA personnel is completed and adapted according to need. • Acts as a resource to other departments regarding the implementation of Quality.
Education
University of Maine
Bachelor’s Degree, Animal Science and Pre-Veterinary Medicine
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