Virginia W.
Site Quality Head Bristol Myers Squibb
- Role
- Site Quality Head at Bristol Myers Squibb
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
Experience
Site Quality Head
Apr 2022 — Present · MA, US
Directs all aspects of site quality programs, systems, operations and compliance activities.Interfaces with Regulatory Agencies (FDA and ROW regulatory agencies) as necessary, leads site regulatory inspections and ensure compliance with the marketing authorization requirements.Ensures that all products are manufactured, tested, stored and distributed in accordance with regulatory and company standards, guides, and procedures and meet the requirements of the Domestic and International regulatory agencies.Ensures site GMP required procedures are in alignment and compliance with BMS Corporate Compliance and Policies and Directives. Provides Quality oversight for Commercial biologics DS manufacturing at Devens, Clinical Biologics DS mfg, Global Biologics Stability testing, and shared quality services for Cell Therapy operations.
Education
Saint Anselm College
B.A., Natural Sciences
2000 — 2003
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