Linda Dang Windsor
- Role
- Director, Product Quality Assurance at Nestlé Health Science
- Location
- San Jose, CA, US
- LinkedIn followers
- 500 followers
Experience
Director, Product Quality Assurance
Apr 2022 — Present
Provide direct Quality oversight of CMC-related activities (including validation and tech transfer) at CMOs/CTLs for Rx and Nx clinical-stage programs and ensure compliance with cGMP, FDA, ICH and EMA regulations, guidelines, and industry standards Develop and implement risk-based Quality strategies including establishing and maintaining phase-appropriate quality systems; proactively identify and mitigate quality risks Liaise between the Qualified Person (QP) and internal/external partners to resolve queries and enable lot release Lead and facilitate Quality Business Review (QBR) meetings between internal and external partners Present at Quality Review Boards (QRBs) as Quality Assurance SME, as necessary Negotiate and maintain relevant and effective Quality Agreements at CMOs/CTLs and ensure adherence to requirements
Education
San Francisco State University
Clinical Trial Design and Management
2011 — 2012
San Francisco State University
B.S, Biology; Physiology
2003 — 2008
Skills
- Aseptic Processing
- Fda
- Standard Operating Procedure (Sop)
- Pharmaceutical Industry
- Quality Control
- Manufacturing
- Trackwise
- Sap
- Lifesciences
- Cross-Functional Team Leadership
- Software Documentation
- Life Sciences
- Biotechnology
- Quality Assurance
- Documentation
- Gmp
- Sop
- Biopharmaceuticals
- Filtration
- Pharmaceuticals
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