Dean Ladefian
Strategic Leader in Program & Project Management | Delivering Results in Complex, High-Impact Environments | Expert in Cross-Functional Leadership & Operational Excellence!
- Role
- Quality and Regulatory Project Manager at Philips
- Location
- New Kensington, PA, US
- LinkedIn followers
- 500 followers
About Dean Ladefian
Welcome to my LinkedIn profile: As a Senior Project & Program Management Executive…
Experience
Quality and Regulatory Project Manager
Aug 2024 — Present · Pittsburgh, PA, US
I manage the CAPA periodic updates to ensure that monthly reports are submitted on time to BioTeknica. I make sure that these reports clearly reflect the status of action plans and stay in line with FDA requirements for the Consent Decree. I work closely with CAPA Owners to address any nonconformances found during audits conducted by BioTeknica(On behalf of the FDA), TUV SUD(Canada) and Therapeutic Goods Administration (Australia) ensuring quick and efficient resolution. Additionally, I oversee inspection activities in various roles, including serving as Quality Reviewer and Request Director, and I manage the distribution of necessary documentation to the relevant parties. Below are my notable accomplishments I’ve consistently delivered accurate updates on time, maintaining a perfect record of on-time submissions to ensure we stay within compliance and avoid financial penalties. I’ve worked closely with subject matter experts from regulatory, quality, clinical, validation, and software design teams to update quality system documents with accuracy, ensuring every revision is comprehensive and precise.
Education
Community College of Allegheny County
Associate's degree
Penn State University
Bachelor of Science - BS
Waynesburg University
Master of Business Administration - MBA
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