Kathleen Dalton
Manager, Quality Assurance - GxP
- Role
- Manager, Quality Assurance - Gxp at PTC Therapeutics, Inc.
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Kathleen Dalton
An accomplished and dedicated quality professional, with vast expertise in internal and supplier audits, regulatory inspections, clinical trial study teams, and product recalls and FARs. Established capabilities in inspection readiness activities, key relationship management, and assessments. Utilizes strong interpersonal and communications skills to guide and develop associates and liaise with cross-functional teams. An analytical and detail-oriented top performer who delivers efficiency and profitability for an organization. CORE COMPETENCIES: GCP / GMP / GLP Regulations; ICH E6 (R2); Internal & Supplier Audits; Inspection Readiness & Regulatory Inspections; CAPA Management; FAR & Recall Management; SOP Management; Sterile Suite Operations; Leadership; Strong Interpersonal & Communication Skills; Organized Planner; Effective Collaborator; Relationship Builder; Resourcefulness
Experience
Manager, Quality Assurance - Gxp
Feb 2023 — Present
Education
The Ohio State University
Associate of Applied Science, Equestrian Science
1984 — 1986
Temple University School of Pharmacy
Master's degree, Quality Assurance and Regulatory Affairs
2009 — 2011
Delaware Valley College
Bachelor's degree, Animal Biology
1994 — 1999
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