Rebecca Dubray
Senior Quality Process Leader - Personalized Healthcare - at Genentech
- Role
- Senior Quality Lead at Genentech
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Rebecca Dubray
I have extensive expertise in quality and regulatory compliance within the Biotechnology and Pharmaceutical industries. I have a proven ability to assess quality systems and work collaboratively with clients to improve processes, ensuring both efficiency and compliance. I am skilled at finding practical solutions while being sensitive to business needs. I establish rapport and credibility by combining QA expertise and solid technical laboratory skills. I have developed successful ground-up quality oversight programs and administer meaningful training and mentoring. I am recognized as a Subject Matter Expert providing compliance leadership on complex issues. Key competency areas: OECD and FDA GLP 21 CFR Part 11 Test Article Characterization Computer Systems Validation Bioanalytical (Immunoassay & LC/MS/MS) GCP ICH E6 GCP, IVDR, MDR, ISO 20916, Supplier Management Nonclinical and Clinical (GCP, ICH E6) laboratory Toxicology Data Integrity
Experience
Senior Quality Lead
Dec 2019 — Present
Supports the Roche/Genentech Organization through the design and delivery of Quality Assurance strategies for Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and Computer Systems (CS). Generates Quality Assurance strategies, evidence and actionable data through the conduct of activities (including audits) to assess the Quality status and be able to demonstrate effective implementation of Quality Assurance to stakeholders and Health Authorities.
Education
Temple University
Master's Degree, Quality Assurance / Regulatory Affairs
McGill University
Bachelor's Degree, Environmental Biology
Skills
- Lims
- Good Laboratory Practice (Glp)
- Biotechnology
- 21 Cfr Part 11
- Immunoassays
- Glp
- Pharmaceutical Industry
- Sop
- Fda
- Drug Development
- Bioanalysis
- Biopharmaceuticals
- Computer System Validation
- Capa
- Validation
- Mass Spectrometry
- Gxp
- CRO
- R&D
- Regulatory Submissions
- Clinical Development
- U.s. Food and Drug Administration (Fda)
- Change Control
- Toxicology
- Standard Operating Procedure (Sop)
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